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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83584

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

Open FDA event record

Event summary

Timeline bucket
April 24, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Centurion Medical Products Corporation

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

33 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 33

PICC Line Accessory Kit CVI4285

Z-0075-2020
Recall number
Z-0075-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018040690 2018061490 2018082790 2018111490 2018111990 2018120390

Distribution pattern

Nationwide domestic distribution.

device · product 2 of 33

PEDIATRIC PICC INSERTION TRAY CVI4450

Z-0076-2020
Recall number
Z-0076-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2017122801 2018021601

Distribution pattern

Nationwide domestic distribution.

device · product 3 of 33

PEDIATRIC PICC INSERTION TRAY CVI4450A

Z-0077-2020
Recall number
Z-0077-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018101250 2018101850 2018110950 2018121150

Distribution pattern

Nationwide domestic distribution.

device · product 4 of 33

NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535

Z-0078-2020
Recall number
Z-0078-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2019020190

Distribution pattern

Nationwide domestic distribution.

device · product 5 of 33

CVC BUNDLE WITHOUT CATH CVI4600

Z-0079-2020
Recall number
Z-0079-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2019022550 2019032250

Distribution pattern

Nationwide domestic distribution.

device · product 6 of 33

PORT AND IO ACCESS DRESSING KIT DT15780A

Z-0080-2020
Recall number
Z-0080-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018120690 2019012490 2019031190

Distribution pattern

Nationwide domestic distribution.

device · product 7 of 33

Cap Change Kit DT20310

Z-0081-2020
Recall number
Z-0081-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2017032780 2017052280 2017070380 2017072480 2017091180

Distribution pattern

Nationwide domestic distribution.

device · product 8 of 33

Neonatal Cap Change Kit DT20315

Z-0082-2020
Recall number
Z-0082-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2017042480 2017061980 2017082880

Distribution pattern

Nationwide domestic distribution.

device · product 9 of 33

CAP CHANGE KIT DYNDC1496B

Z-0083-2020
Recall number
Z-0083-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018101590 2019020890 2019030890 2019032290

Distribution pattern

Nationwide domestic distribution.

device · product 10 of 33

INFUSA PORT KIT DYNDC1840E

Z-0084-2020
Recall number
Z-0084-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018081790

Distribution pattern

Nationwide domestic distribution.

device · product 11 of 33

INFUSA PORT KIT DYNDC1840F

Z-0085-2020
Recall number
Z-0085-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018092090 2018100890 2018122890 2019032790

Distribution pattern

Nationwide domestic distribution.

device · product 12 of 33

STERILE CAP CHANGE KIT DYNDC1946B

Z-0086-2020
Recall number
Z-0086-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018101790 2018092790 2019030690

Distribution pattern

Nationwide domestic distribution.

device · product 13 of 33

CAP BUNDLE KIT DYNDC2137

Z-0087-2020
Recall number
Z-0087-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018091390 2018120590

Distribution pattern

Nationwide domestic distribution.

device · product 14 of 33

TRIPLE LUMEN BUNDLE KIT ECVC1540

Z-0088-2020
Recall number
Z-0088-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2017102650 2018010550 2018020850 2018042650 2018071650 2018081050 2018090450 2018100950 2018101750 2019032250

Distribution pattern

Nationwide domestic distribution.

device · product 15 of 33

CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840

Z-0089-2020
Recall number
Z-0089-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018012450 2018020850 2018062750 2018071250 2018090650 2018101250 2019022550

Distribution pattern

Nationwide domestic distribution.

device · product 16 of 33

CVC BUNDLE, 20CM, 4L, PI ECVC5095

Z-0090-2020
Recall number
Z-0090-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018031450 2018040950 2018050750 2018053150 2018071350

Distribution pattern

Nationwide domestic distribution.

device · product 17 of 33

CVC BUNDLE, 20CM, 3L, PI ECVC5120

Z-0091-2020
Recall number
Z-0091-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018030150 2018071350

Distribution pattern

Nationwide domestic distribution.

device · product 18 of 33

CVC BUNDLE, 20CM, 3L, PI ECVC5120A

Z-0092-2020
Recall number
Z-0092-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018032350 2018081050 2018091950 2018112750 2018121850 2019012450 2019013050

Distribution pattern

Nationwide domestic distribution.

device · product 19 of 33

CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060

Z-0093-2020
Recall number
Z-0093-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018032350 2018081050 2018091950 2018112750 2018121850 2019012450 2019013050

Distribution pattern

Nationwide domestic distribution.

device · product 20 of 33

CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065

Z-0094-2020
Recall number
Z-0094-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018082450 2018091850 2018121850 2018122150 2019011550 2019012450 2019013050

Distribution pattern

Nationwide domestic distribution.

device · product 21 of 33

CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070

Z-0095-2020
Recall number
Z-0095-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018081550 2018091750 2018100850

Distribution pattern

Nationwide domestic distribution.

device · product 22 of 33

CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355

Z-0096-2020
Recall number
Z-0096-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018030250 2018072750 2018090450 2018091750 2018122650 2019011050 2019020450 2019031350 2019040150

Distribution pattern

Nationwide domestic distribution.

device · product 23 of 33

CENTRAL LINE BUNDLE ECVC6375

Z-0097-2020
Recall number
Z-0097-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018091150 2018101050 2018121950 2019010950

Distribution pattern

Nationwide domestic distribution.

device · product 24 of 33

CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545

Z-0098-2020
Recall number
Z-0098-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018102950 2018110250

Distribution pattern

Nationwide domestic distribution.

device · product 25 of 33

CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A

Z-0099-2020
Recall number
Z-0099-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2019041050

Distribution pattern

Nationwide domestic distribution.

device · product 26 of 33

OR VANTEX 7FR 3L 16CM CVC ECVC6665

Z-0100-2020
Recall number
Z-0100-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018111950 2019031350 2019040550

Distribution pattern

Nationwide domestic distribution.

device · product 27 of 33

VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670

Z-0101-2020
Recall number
Z-0101-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018111950 2019031350 2019040550

Distribution pattern

Nationwide domestic distribution.

device · product 28 of 33

IV START KIT IV8440

Z-0102-2020
Recall number
Z-0102-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2017061980 2017071780 2017091180 2017102380 2017121880 2018012280 2018022680 2018041680 2018070980

Distribution pattern

Nationwide domestic distribution.

device · product 29 of 33

IV SECUREMENT KIT IVS3405

Z-0103-2020
Recall number
Z-0103-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2019031490 2017100690 2017110790 2018011790 2018050490 2018060590 2018072490 2018110190 2019011490 2019020690

Distribution pattern

Nationwide domestic distribution.

device · product 30 of 33

IV KIT - SORBAVIEW IVS3475

Z-0104-2020
Recall number
Z-0104-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2019031490 2018070690 2018100290 2018100390 2018121390 2019020690

Distribution pattern

Nationwide domestic distribution.

device · product 31 of 33

INVASIVE PROCEDURE TRAY MNS9510

Z-0105-2020
Recall number
Z-0105-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2017100990 2017120490

Distribution pattern

Nationwide domestic distribution.

device · product 32 of 33

TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040

Z-0106-2020
Recall number
Z-0106-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2018110150 2018120350 2018121050 2019021150 2019021550

Distribution pattern

Nationwide domestic distribution.

device · product 33 of 33

UVC TRAY UVT875

Z-0107-2020
Recall number
Z-0107-2020
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Quantity
181965 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Code information

2017051690 2017052390 2017071390 2017072490 2017082490 2017090790 2017100490 2018012590 2018062890 2018071290 2018081990 2018101290

Distribution pattern

Nationwide domestic distribution.