Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82703

183 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 18, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet Cardiovascular, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

183 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 183

Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087

Z-1498-2019
Recall number
Z-1498-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000062267, 3000065087

Distribution pattern

Nationwide

device · product 2 of 183

Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962

Z-1499-2019
Recall number
Z-1499-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000047630 3000050482 3000055980 3000060726 3000066813 3000068491 3000070813 3000074323

Distribution pattern

Nationwide

device · product 3 of 183

Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539

Z-1500-2019
Recall number
Z-1500-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: Batch 3000043059 3000051269 3000067520 3000072508 3000080853

Distribution pattern

Nationwide

device · product 4 of 183

Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690

Z-1501-2019
Recall number
Z-1501-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044416 3000049077 3000053102 3000054957 3000056257 3000061306 3000070701 3000072685

Distribution pattern

Nationwide

device · product 5 of 183

Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346

Z-1502-2019
Recall number
Z-1502-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043292 3000047704 3000050576 3000052263 3000060362 3000065492 3000066201 3000071202

Distribution pattern

Nationwide

device · product 6 of 183

Maquet Getinge-BEQ-T-22800 Material: 701049506

Z-1503-2019
Recall number
Z-1503-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000046489 3000055506

Distribution pattern

Nationwide

device · product 7 of 183

Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510

Z-1504-2019
Recall number
Z-1504-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000069367

Distribution pattern

Nationwide

device · product 8 of 183

Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994

Z-1505-2019
Recall number
Z-1505-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041414 3000047036 3000050575 3000051657

Distribution pattern

Nationwide

device · product 9 of 183

Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060

Z-1506-2019
Recall number
Z-1506-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000049556 3000067468

Distribution pattern

Nationwide

device · product 10 of 183

Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228

Z-1507-2019
Recall number
Z-1507-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048233 3000048397 3000054333 3000058183 3000069469 3000074100

Distribution pattern

Nationwide

device · product 11 of 183

Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253

Z-1508-2019
Recall number
Z-1508-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041126 3000053053 3000054958 3000055326 3000064943 3000066814 3000071782

Distribution pattern

Nationwide

device · product 12 of 183

Maquet Getinge-BEQ-TOP 22701 Material: 701050790

Z-1509-2019
Recall number
Z-1509-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000060359 3000060495 3000062725 3000071781

Distribution pattern

Nationwide

device · product 13 of 183

Maquet Getinge-BEQ-TOP 4901 Material: 701050839

Z-1510-2019
Recall number
Z-1510-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000063714 3000080869

Distribution pattern

Nationwide

device · product 14 of 183

Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859

Z-1511-2019
Recall number
Z-1511-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000047911 3000054555 3000062794 3000071204 3000072306 3000076555

Distribution pattern

Nationwide

device · product 15 of 183

Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966

Z-1512-2019
Recall number
Z-1512-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000063810 3000068490 3000071784 3000076463

Distribution pattern

Nationwide

device · product 16 of 183

Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975

Z-1513-2019
Recall number
Z-1513-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043848 3000050583 3000050645 3000053626 3000054146

Distribution pattern

Nationwide

device · product 17 of 183

Maquet Getinge-BEQ-TOP 15705 Material: 701051122

Z-1514-2019
Recall number
Z-1514-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044566 3000046394 3000049202 3000054550 3000058043 3000060239 3000066276 3000069368 3000071833 3000074339 3000080701 3000081598

Distribution pattern

Nationwide

device · product 18 of 183

Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179

Z-1515-2019
Recall number
Z-1515-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045170 3000058051 3000062455 3000065508

Distribution pattern

Nationwide

device · product 19 of 183

Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515

Z-1516-2019
Recall number
Z-1516-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041127 3000049458 3000061103 3000065550 3000071378 3000075338 3000081601

Distribution pattern

Nationwide

device · product 20 of 183

Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791

Z-1517-2019
Recall number
Z-1517-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043651 3000047320 3000062721 3000064716 3000072309

Distribution pattern

Nationwide

device · product 21 of 183

Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285

Z-1518-2019
Recall number
Z-1518-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048235 3000056129 3000059730 3000065496 3000070700 3000073428

Distribution pattern

Nationwide

device · product 22 of 183

Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287

Z-1519-2019
Recall number
Z-1519-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: Batch 3000065552 3000070971 3000074623 3000076634 3000080868

Distribution pattern

Nationwide

device · product 23 of 183

Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324

Z-1520-2019
Recall number
Z-1520-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000073972

Distribution pattern

Nationwide

device · product 24 of 183

Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461

Z-1521-2019
Recall number
Z-1521-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000065224 3000074124

Distribution pattern

Nationwide

device · product 25 of 183

Maquet Getinge-BO-TOP 30300 Material:701052623

Z-1522-2019
Recall number
Z-1522-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043293 3000045086 3000050830 3000058048

Distribution pattern

Nationwide

device · product 26 of 183

Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843

Z-1523-2019
Recall number
Z-1523-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000058044 3000062463 3000075430

Distribution pattern

Nationwide

device · product 27 of 183

Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319

Z-1524-2019
Recall number
Z-1524-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043054 3000049462 3000058326 3000062722 3000069369 3000073168

Distribution pattern

Nationwide

device · product 28 of 183

Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361

Z-1525-2019
Recall number
Z-1525-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000071966 3000074121 3000075280 3000077082

Distribution pattern

Nationwide

device · product 29 of 183

Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486

Z-1526-2019
Recall number
Z-1526-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048716 3000054549 3000061302 3000067224 3000070815 3000072509 3000076464

Distribution pattern

Nationwide

device · product 30 of 183

Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752

Z-1527-2019
Recall number
Z-1527-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000056255

Distribution pattern

Nationwide

device · product 31 of 183

Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754

Z-1528-2019
Recall number
Z-1528-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000054158

Distribution pattern

Nationwide

device · product 32 of 183

Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845

Z-1529-2019
Recall number
Z-1529-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048232 3000049610 3000056811 3000063949 3000067795 3000071203 3000071783

Distribution pattern

Nationwide

device · product 33 of 183

Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906

Z-1530-2019
Recall number
Z-1530-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000054551 3000065085

Distribution pattern

Nationwide

device · product 34 of 183

Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150

Z-1531-2019
Recall number
Z-1531-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000049611 3000058052 3000062459 3000066196

Distribution pattern

Nationwide

device · product 35 of 183

Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295

Z-1532-2019
Recall number
Z-1532-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000057379 3000063707 3000066885 3000071785 3000071806 3000073164

Distribution pattern

Nationwide

device · product 36 of 183

Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438

Z-1533-2019
Recall number
Z-1533-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043291 3000044425 3000046811 3000047912 3000052203 3000053795 3000059174 3000062478 3000066197 3000067469 3000070703 3000074122 3000075896

Distribution pattern

Nationwide

device · product 37 of 183

Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776

Z-1534-2019
Recall number
Z-1534-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043295 3000047248 3000047254 3000055638 3000062271 3000065551 3000069074 3000075386

Distribution pattern

Nationwide

device · product 38 of 183

Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874

Z-1535-2019
Recall number
Z-1535-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044426 3000049067 3000053796 3000054622 3000067221 3000067796 3000072147 3000074175

Distribution pattern

Nationwide

device · product 39 of 183

Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912

Z-1536-2019
Recall number
Z-1536-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000055636

Distribution pattern

Nationwide

device · product 40 of 183

Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142

Z-1537-2019
Recall number
Z-1537-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044427 3000054806 3000059172 3000069470

Distribution pattern

Nationwide

device · product 41 of 183

Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372

Z-1538-2019
Recall number
Z-1538-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000061506

Distribution pattern

Nationwide

device · product 42 of 183

Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388

Z-1539-2019
Recall number
Z-1539-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044291 3000046812 3000048395 3000051270 3000054144 3000055979 3000058735 3000061304 3000063708 3000066691 3000070702 3000072307 3000075122

Distribution pattern

Nationwide

device · product 43 of 183

Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601

Z-1540-2019
Recall number
Z-1540-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048238 3000061109 3000069075

Distribution pattern

Nationwide

device · product 44 of 183

Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:

Z-1541-2019
Recall number
Z-1541-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000055504

Distribution pattern

Nationwide

device · product 45 of 183

Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862

Z-1542-2019
Recall number
Z-1542-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000047632 3000052206 3000055637 3000060482 3000067466

Distribution pattern

Nationwide

device · product 46 of 183

Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866

Z-1543-2019
Recall number
Z-1543-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045221 3000049201 3000054750 3000062046 3000065497 3000067793 3000069723 3000072247 3000075339 3000080720 3000084636

Distribution pattern

Nationwide

device · product 47 of 183

Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993

Z-1544-2019
Recall number
Z-1544-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000054751 3000055509 3000061510 3000066891 3000075388 3000080435 3000080699 3000081533

Distribution pattern

Nationwide

device · product 48 of 183

Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995

Z-1545-2019
Recall number
Z-1545-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000058045 3000069467 3000072507 3000080702

Distribution pattern

Nationwide

device · product 49 of 183

Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041

Z-1546-2019
Recall number
Z-1546-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041540

Distribution pattern

Nationwide

device · product 50 of 183

Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368

Z-1547-2019
Recall number
Z-1547-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041396 3000044053 3000047317 3000050887 3000058131 3000060487 3000060723 3000062458 3000064724 3000071815 3000071817

Distribution pattern

Nationwide

device · product 51 of 183

Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310

Z-1548-2019
Recall number
Z-1548-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043296 3000046809 3000047251 3000050480 3000054805 3000060727 3000066887

Distribution pattern

Nationwide

device · product 52 of 183

Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473

Z-1549-2019
Recall number
Z-1549-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045173 3000046396 3000046746

Distribution pattern

Nationwide

device · product 53 of 183

Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613

Z-1550-2019
Recall number
Z-1550-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041407 3000069806

Distribution pattern

Nationwide

device · product 54 of 183

Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899

Z-1551-2019
Recall number
Z-1551-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000057630 3000083783

Distribution pattern

Nationwide

device · product 55 of 183

Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071

Z-1552-2019
Recall number
Z-1552-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044877 3000045089 3000045951

Distribution pattern

Nationwide

device · product 56 of 183

Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149

Z-1553-2019
Recall number
Z-1553-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000064725

Distribution pattern

Nationwide

device · product 57 of 183

Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255

Z-1554-2019
Recall number
Z-1554-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041007 3000044052 3000045730 3000047318 3000054334 3000054615 3000063091

Distribution pattern

Nationwide

device · product 58 of 183

Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505

Z-1555-2019
Recall number
Z-1555-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000046810 3000054159 3000066889 3000074123

Distribution pattern

Nationwide

device · product 59 of 183

Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560

Z-1556-2019
Recall number
Z-1556-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: Batch 3000041128 3000045731 3000050577 3000052947 3000054617 3000054955 3000057631 3000071818

Distribution pattern

Nationwide

device · product 60 of 183

Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590

Z-1557-2019
Recall number
Z-1557-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000071399

Distribution pattern

Nationwide

device · product 61 of 183

Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701

Z-1558-2019
Recall number
Z-1558-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000054160 3000057639 3000058046

Distribution pattern

Nationwide

device · product 62 of 183

Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757

Z-1559-2019
Recall number
Z-1559-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000051271 3000057632 3000062460 3000066202 3000069076 3000073425 3000076761 3000080703

Distribution pattern

Nationwide

device · product 63 of 183

Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804

Z-1560-2019
Recall number
Z-1560-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000057680 3000066687 3000075125 3000075898 3000080799

Distribution pattern

Nationwide

device · product 64 of 183

Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825

Z-1561-2019
Recall number
Z-1561-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000071198

Distribution pattern

Nationwide

device · product 65 of 183

Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831

Z-1562-2019
Recall number
Z-1562-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000066688 3000080800

Distribution pattern

Nationwide

device · product 66 of 183

Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834

Z-1563-2019
Recall number
Z-1563-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041415 3000044885 3000077738

Distribution pattern

Nationwide

device · product 67 of 183

Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867

Z-1564-2019
Recall number
Z-1564-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045174 3000049559 3000057376 3000063289 3000069864 3000074097

Distribution pattern

Nationwide

device · product 68 of 183

Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965

Z-1565-2019
Recall number
Z-1565-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000046123 3000059176

Distribution pattern

Nationwide

device · product 69 of 183

Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992

Z-1566-2019
Recall number
Z-1566-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043679 3000047252 3000050833 3000053134 3000054956 3000056048 3000060481 3000063710 3000067185 3000071400 3000073429 3000075387 3000075899

Distribution pattern

Nationwide

device · product 70 of 183

Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190

Z-1567-2019
Recall number
Z-1567-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000069382 3000074502

Distribution pattern

Nationwide

device · product 71 of 183

Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209

Z-1568-2019
Recall number
Z-1568-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000049454 3000054311 3000054314 3000055640

Distribution pattern

Nationwide

device · product 72 of 183

Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504

Z-1569-2019
Recall number
Z-1569-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044419 3000045727 3000065141

Distribution pattern

Nationwide

device · product 73 of 183

Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510

Z-1570-2019
Recall number
Z-1570-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000050481 3000052617 3000054413 3000054961 3000055976

Distribution pattern

Nationwide

device · product 74 of 183

Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512

Z-1571-2019
Recall number
Z-1571-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000056132

Distribution pattern

Nationwide

device · product 75 of 183

Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620

Z-1572-2019
Recall number
Z-1572-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043297 3000045729 3000046485 3000049608 3000052615 3000054322 3000056259 3000062050

Distribution pattern

Nationwide

device · product 76 of 183

Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765

Z-1573-2019
Recall number
Z-1573-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043680 3000046039 3000049205 3000052613 3000055536 3000062791

Distribution pattern

Nationwide

device · product 77 of 183

Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770

Z-1574-2019
Recall number
Z-1574-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041328 3000041619

Distribution pattern

Nationwide

device · product 78 of 183

Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823

Z-1575-2019
Recall number
Z-1575-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043849 3000046392

Distribution pattern

Nationwide

device · product 79 of 183

Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097

Z-1576-2019
Recall number
Z-1576-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000055324 3000061509

Distribution pattern

Nationwide

device · product 80 of 183

Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291

Z-1577-2019
Recall number
Z-1577-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000062472 3000071380

Distribution pattern

Nationwide

device · product 81 of 183

Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366

Z-1578-2019
Recall number
Z-1578-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044415 3000046393 3000046736

Distribution pattern

Nationwide

device · product 82 of 183

Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551

Z-1579-2019
Recall number
Z-1579-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041542 3000046483 3000049065 3000055328 3000057682 3000060483 3000063712

Distribution pattern

Nationwide

device · product 83 of 183

Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583

Z-1580-2019
Recall number
Z-1580-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000046122 3000062040

Distribution pattern

Nationwide

device · product 84 of 183

Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664

Z-1581-2019
Recall number
Z-1581-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041468 3000053105 3000054552 3000057683 3000059795 3000065086 3000067186 3000069077 3000071375 3000072684 3000074341 3000075431 3000078942 3000080722 3000081524 3000084050

Distribution pattern

Nationwide

device · product 85 of 183

Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883

Z-1582-2019
Recall number
Z-1582-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041327 3000042148 3000042819 3000046732 3000054315 3000055642 3000062038 3000066689

Distribution pattern

Nationwide

device · product 86 of 183

Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203

Z-1583-2019
Recall number
Z-1583-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000053530 3000058323

Distribution pattern

Nationwide

device · product 87 of 183

Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280

Z-1584-2019
Recall number
Z-1584-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044421

Distribution pattern

Nationwide

device · product 88 of 183

Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350

Z-1585-2019
Recall number
Z-1585-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044413 3000049064 3000050885 3000054157 3000058832 3000062461 3000065084

Distribution pattern

Nationwide

device · product 89 of 183

Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372

Z-1586-2019
Recall number
Z-1586-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000047035 3000051157 3000056254 3000059729 3000062036 3000063395

Distribution pattern

Nationwide

device · product 90 of 183

Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577

Z-1587-2019
Recall number
Z-1587-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000066690 3000072826 3000080852

Distribution pattern

Nationwide

device · product 91 of 183

Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668

Z-1588-2019
Recall number
Z-1588-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000056047 3000058250 3000066199

Distribution pattern

Nationwide

device · product 92 of 183

Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837

Z-1589-2019
Recall number
Z-1589-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041469

Distribution pattern

Nationwide

device · product 93 of 183

Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008

Z-1590-2019
Recall number
Z-1590-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000042629 3000057758

Distribution pattern

Nationwide

device · product 94 of 183

Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168

Z-1591-2019
Recall number
Z-1591-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000042630 3000053054 3000054960 3000058830

Distribution pattern

Nationwide

device · product 95 of 183

Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395

Z-1592-2019
Recall number
Z-1592-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044423

Distribution pattern

Nationwide

device · product 96 of 183

Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797

Z-1593-2019
Recall number
Z-1593-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048720 3000058736 3000063950 3000070973 3000072680 3000075283

Distribution pattern

Nationwide

device · product 97 of 183

Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798

Z-1594-2019
Recall number
Z-1594-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000042989 3000058142

Distribution pattern

Nationwide

device · product 98 of 183

Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004

Z-1595-2019
Recall number
Z-1595-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045083 3000046399

Distribution pattern

Nationwide

device · product 99 of 183

Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006

Z-1596-2019
Recall number
Z-1596-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000059175

Distribution pattern

Nationwide

device · product 100 of 183

Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011

Z-1597-2019
Recall number
Z-1597-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000064952

Distribution pattern

Nationwide

device · product 101 of 183

Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058

Z-1598-2019
Recall number
Z-1598-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043158 3000045091 3000046739 3000050831 3000062044 3000065548

Distribution pattern

Nationwide

device · product 102 of 183

Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072

Z-1599-2019
Recall number
Z-1599-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000062737 3000068119

Distribution pattern

Nationwide

device · product 103 of 183

Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078

Z-1600-2019
Recall number
Z-1600-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000047631 3000054421 3000063290 3000071804 3000073166 3000075337

Distribution pattern

Nationwide

device · product 104 of 183

Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093

Z-1601-2019
Recall number
Z-1601-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045728 3000051160 3000058050

Distribution pattern

Nationwide

device · product 105 of 183

Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113

Z-1602-2019
Recall number
Z-1602-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000060038

Distribution pattern

Nationwide

device · product 106 of 183

Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115

Z-1603-2019
Recall number
Z-1603-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043613 3000076067

Distribution pattern

Nationwide

device · product 107 of 183

Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127

Z-1604-2019
Recall number
Z-1604-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000053531 3000060033 3000067120

Distribution pattern

Nationwide

device · product 108 of 183

Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133

Z-1605-2019
Recall number
Z-1605-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044424 3000046488 3000049459 3000055093 3000060357

Distribution pattern

Nationwide

device · product 109 of 183

Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146

Z-1606-2019
Recall number
Z-1606-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000075713

Distribution pattern

Nationwide

device · product 110 of 183

Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213

Z-1607-2019
Recall number
Z-1607-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000047192 3000049558 3000067521

Distribution pattern

Nationwide

device · product 111 of 183

Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266

Z-1608-2019
Recall number
Z-1608-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044290 3000046395

Distribution pattern

Nationwide

device · product 112 of 183

Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280

Z-1609-2019
Recall number
Z-1609-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000071199 3000081153

Distribution pattern

Nationwide

device · product 113 of 183

Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334

Z-1610-2019
Recall number
Z-1610-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000071200 3000081154 3000084780

Distribution pattern

Nationwide

device · product 114 of 183

Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366

Z-1611-2019
Recall number
Z-1611-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000065493

Distribution pattern

Nationwide

device · product 115 of 183

Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368

Z-1612-2019
Recall number
Z-1612-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043162

Distribution pattern

Nationwide

device · product 116 of 183

Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370

Z-1613-2019
Recall number
Z-1613-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048718 3000052045 3000060037 3000074174

Distribution pattern

Nationwide

device · product 117 of 183

Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385

Z-1614-2019
Recall number
Z-1614-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048398 3000075385 3000075472

Distribution pattern

Nationwide

device · product 118 of 183

Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390

Z-1615-2019
Recall number
Z-1615-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000048719 3000062269 3000074321 3000077543

Distribution pattern

Nationwide

device · product 119 of 183

Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417

Z-1616-2019
Recall number
Z-1616-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000061104

Distribution pattern

Nationwide

device · product 120 of 183

Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424

Z-1617-2019
Recall number
Z-1617-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000065091

Distribution pattern

Nationwide

device · product 121 of 183

Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426

Z-1618-2019
Recall number
Z-1618-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000054667 3000067797 3000073970 3000076941

Distribution pattern

Nationwide

device · product 122 of 183

Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428

Z-1619-2019
Recall number
Z-1619-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000061513 3000071803 3000075279 3000077546

Distribution pattern

Nationwide

device · product 123 of 183

Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430

Z-1620-2019
Recall number
Z-1620-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000060035 3000065494 3000067883 3000071809 3000074480 3000075340 3000077550

Distribution pattern

Nationwide

device · product 124 of 183

Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434

Z-1621-2019
Recall number
Z-1621-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000059445 3000062029 3000062476 3000080867

Distribution pattern

Nationwide

device · product 125 of 183

Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444

Z-1622-2019
Recall number
Z-1622-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000058085

Distribution pattern

Nationwide

device · product 126 of 183

Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460

Z-1623-2019
Recall number
Z-1623-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000081747

Distribution pattern

Nationwide

device · product 127 of 183

Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473

Z-1624-2019
Recall number
Z-1624-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000074399

Distribution pattern

Nationwide

device · product 128 of 183

Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490

Z-1625-2019
Recall number
Z-1625-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000074503 3000078944 3000081155

Distribution pattern

Nationwide

device · product 129 of 183

Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516

Z-1626-2019
Recall number
Z-1626-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000083879

Distribution pattern

Nationwide

device · product 130 of 183

Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518

Z-1627-2019
Recall number
Z-1627-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000083880

Distribution pattern

Nationwide

device · product 131 of 183

Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520

Z-1628-2019
Recall number
Z-1628-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000079888 3000081748

Distribution pattern

Nationwide

device · product 132 of 183

Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01

Z-1629-2019
Recall number
Z-1629-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000078425

Distribution pattern

Nationwide

device · product 133 of 183

Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01

Z-1630-2019
Recall number
Z-1630-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000077756 3000078014

Distribution pattern

Nationwide

device · product 134 of 183

Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01

Z-1631-2019
Recall number
Z-1631-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000079611

Distribution pattern

Nationwide

device · product 135 of 183

Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01

Z-1632-2019
Recall number
Z-1632-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000053103 3000066198 3000071830 3000073677

Distribution pattern

Nationwide

device · product 136 of 183

Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02

Z-1633-2019
Recall number
Z-1633-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000076147

Distribution pattern

Nationwide

device · product 137 of 183

Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01

Z-1634-2019
Recall number
Z-1634-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000079889

Distribution pattern

Nationwide

device · product 138 of 183

Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02

Z-1635-2019
Recall number
Z-1635-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000041467 3000050581 3000055641 3000060358 3000067467 3000073974 3000083165

Distribution pattern

Nationwide

device · product 139 of 183

Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01

Z-1636-2019
Recall number
Z-1636-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000042145 3000056049

Distribution pattern

Nationwide

device · product 140 of 183

Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01

Z-1637-2019
Recall number
Z-1637-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000077553 3000084779

Distribution pattern

Nationwide

device · product 141 of 183

Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01

Z-1638-2019
Recall number
Z-1638-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045166 3000050578 3000054620

Distribution pattern

Nationwide

device · product 142 of 183

Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01

Z-1639-2019
Recall number
Z-1639-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000077742

Distribution pattern

Nationwide

device · product 143 of 183

Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01

Z-1640-2019
Recall number
Z-1640-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000074733 3000081599

Distribution pattern

Nationwide

device · product 144 of 183

Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01

Z-1641-2019
Recall number
Z-1641-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000046120 3000062048 3000068120

Distribution pattern

Nationwide

device · product 145 of 183

Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01

Z-1642-2019
Recall number
Z-1642-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000079891

Distribution pattern

Nationwide

device · product 146 of 183

Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01

Z-1643-2019
Recall number
Z-1643-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000077744

Distribution pattern

Nationwide

device · product 147 of 183

Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01

Z-1644-2019
Recall number
Z-1644-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000080434 3000081004

Distribution pattern

Nationwide

device · product 148 of 183

Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01

Z-1645-2019
Recall number
Z-1645-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000068802 3000071398 3000074190 3000076543

Distribution pattern

Nationwide

device · product 149 of 183

Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:

Z-1646-2019
Recall number
Z-1646-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: (1) 3000051652 3000054808 3000058733 3000062473 3000071201 3000073170 3000075123 (2) 3000076148 3000081600

Distribution pattern

Nationwide

device · product 150 of 183

Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01

Z-1647-2019
Recall number
Z-1647-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000080713

Distribution pattern

Nationwide

device · product 151 of 183

Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02

Z-1648-2019
Recall number
Z-1648-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000049066 3000053533

Distribution pattern

Nationwide

device · product 152 of 183

Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01

Z-1649-2019
Recall number
Z-1649-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000077084 3000084911

Distribution pattern

Nationwide

device · product 153 of 183

Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01

Z-1650-2019
Recall number
Z-1650-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000050941 3000053625 3000069865 3000071831 3000080721 3000083489

Distribution pattern

Nationwide

device · product 154 of 183

Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01

Z-1651-2019
Recall number
Z-1651-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000077890 3000079608

Distribution pattern

Nationwide

device · product 155 of 183

Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01

Z-1652-2019
Recall number
Z-1652-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000076762 3000077899 3000078013 3000084649

Distribution pattern

Nationwide

device · product 156 of 183

Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack

Z-1653-2019
Recall number
Z-1653-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: (1) 3000050886 (2) 3000066508, 3000081906

Distribution pattern

Nationwide

device · product 157 of 183

Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01

Z-1654-2019
Recall number
Z-1654-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000044876 3000047906 3000051750 3000056130 3000061303 3000062457 3000071820

Distribution pattern

Nationwide

device · product 158 of 183

Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01

Z-1655-2019
Recall number
Z-1655-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000074735 3000080798

Distribution pattern

Nationwide

device · product 159 of 183

Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01

Z-1656-2019
Recall number
Z-1656-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000046112 3000051162 3000056133 3000062045 3000071402 3000074895 3000075715 3000078940

Distribution pattern

Nationwide

device · product 160 of 183

Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01

Z-1657-2019
Recall number
Z-1657-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000056807 3000058047 3000061214 3000064945 3000068116 3000071379 3000071832 3000080848 3000081908

Distribution pattern

Nationwide

device · product 161 of 183

Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm

Z-1658-2019
Recall number
Z-1658-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: (1)3000070816, 3000072682 (2) 3000074736, 3000077083, 3000080988, 3000082175 ***Updated 3/26/20*** Extended: 3000087051

Distribution pattern

Nationwide

device · product 162 of 183

Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01

Z-1659-2019
Recall number
Z-1659-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045085 3000047033 3000051653 3000056258 3000062266

Distribution pattern

Nationwide

device · product 163 of 183

Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01

Z-1660-2019
Recall number
Z-1660-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000068115 3000081002 3000083490

Distribution pattern

Nationwide

device · product 164 of 183

Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01

Z-1661-2019
Recall number
Z-1661-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000080724 3000084928

Distribution pattern

Nationwide

device · product 165 of 183

Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01

Z-1662-2019
Recall number
Z-1662-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000060743 3000066277 3000069078 3000073171 3000074176 3000076468 3000080999 3000081905 3000085277

Distribution pattern

Nationwide

device · product 166 of 183

Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack

Z-1663-2019
Recall number
Z-1663-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: (1)3000058184, 3000067382, 3000069380, 3000071967, 3000074322 (2)3000077734

Distribution pattern

Nationwide

device · product 167 of 183

Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01

Z-1664-2019
Recall number
Z-1664-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000076856 3000077891

Distribution pattern

Nationwide

device · product 168 of 183

Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01

Z-1665-2019
Recall number
Z-1665-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000059724

Distribution pattern

Nationwide

device · product 169 of 183

Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01

Z-1666-2019
Recall number
Z-1666-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000043846 3000047255 3000052044 3000061508 3000074098 3000078928 3000079607

Distribution pattern

Nationwide

device · product 170 of 183

Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac

Z-1667-2019
Recall number
Z-1667-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: (1) 3000067384, 3000070970 (2) 3000074734, 3000081003

Distribution pattern

Nationwide

device · product 171 of 183

Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02

Z-1668-2019
Recall number
Z-1668-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000058180 3000062474

Distribution pattern

Nationwide

device · product 172 of 183

Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W

Z-1669-2019
Recall number
Z-1669-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: (1) 3000042627 (2) 3000047034 (3) 3000058143

Distribution pattern

Nationwide

device · product 173 of 183

Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01

Z-1670-2019
Recall number
Z-1670-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000074094

Distribution pattern

Nationwide

device · product 174 of 183

Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01

Z-1671-2019
Recall number
Z-1671-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000074095 3000082174

Distribution pattern

Nationwide

device · product 175 of 183

Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01

Z-1672-2019
Recall number
Z-1672-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000079609

Distribution pattern

Nationwide

device · product 176 of 183

Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01

Z-1673-2019
Recall number
Z-1673-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000058327

Distribution pattern

Nationwide

device · product 177 of 183

Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02

Z-1674-2019
Recall number
Z-1674-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000051158 3000061507 3000067518 3000069468

Distribution pattern

Nationwide

device · product 178 of 183

Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01

Z-1675-2019
Recall number
Z-1675-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000078943

Distribution pattern

Nationwide

device · product 179 of 183

Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01

Z-1676-2019
Recall number
Z-1676-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000069722

Distribution pattern

Nationwide

device · product 180 of 183

Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01

Z-1677-2019
Recall number
Z-1677-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000045168 3000046484 3000062270 3000064946 3000084054

Distribution pattern

Nationwide

device · product 181 of 183

Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01

Z-1678-2019
Recall number
Z-1678-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000053797 3000057760 3000063952 3000067187 3000069726 3000072683 3000075716

Distribution pattern

Nationwide

device · product 182 of 183

Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01

Z-1679-2019
Recall number
Z-1679-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000076765

Distribution pattern

Nationwide

device · product 183 of 183

Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

Z-1680-2019
Recall number
Z-1680-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information

Batch Numbers: 3000077081

Distribution pattern

Nationwide