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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80811

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

Open FDA event record

Event summary

Timeline bucket
July 20, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
B. Braun Medical, Inc.

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

93 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 93

CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3313-2018
Recall number
Z-3313-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
600

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61610255

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 2 of 93

CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3314-2018
Recall number
Z-3314-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
108

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61602878

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 3 of 93

CNBFX350C CONTIPLEX CONT NERVE BLOCK, Material Number 331672 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3315-2018
Recall number
Z-3315-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
300

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61588352

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 4 of 93

CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3316-2018
Recall number
Z-3316-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
168

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61597400

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 5 of 93

CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3317-2018
Recall number
Z-3317-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
5460

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598571, 61605368

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 6 of 93

CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3318-2018
Recall number
Z-3318-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
468

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61597399

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 7 of 93

CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3319-2018
Recall number
Z-3319-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
10944

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61611404, 61622440

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 8 of 93

CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3320-2018
Recall number
Z-3320-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
864

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61610286, 61619554

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 9 of 93

CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3321-2018
Recall number
Z-3321-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1848

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598006, 61602664

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 10 of 93

CNB200S CONTIPLEX INSULATED TUOHY NDL, Material Number 331697 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3322-2018
Recall number
Z-3322-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
144

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600669

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 11 of 93

CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3323-2018
Recall number
Z-3323-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1370

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598523, 61601873, 61611463

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 12 of 93

CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3324-2018
Recall number
Z-3324-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
4510

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61595528, 61600766, 61606969, 61616955

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 13 of 93

SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3325-2018
Recall number
Z-3325-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1020

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598215, 61602690, 61610144

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 14 of 93

CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3326-2018
Recall number
Z-3326-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
120

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61610284

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 15 of 93

CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3327-2018
Recall number
Z-3327-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
430

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61606946, 61613536, 61619213

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 16 of 93

CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3328-2018
Recall number
Z-3328-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
190

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598015

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 17 of 93

CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3329-2018
Recall number
Z-3329-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
590

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61615716, 61616929

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 18 of 93

CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3330-2018
Recall number
Z-3330-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
3120

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61588408, 61596321, 61618693

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 19 of 93

CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3331-2018
Recall number
Z-3331-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
60760

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61595534, 61596125, 61601680, 61604904, 61607912, 61607913, 61607914, 61607915, 61607911, 61607916, 61607917, 61607918, 61607921, 61609180, 61610345, 61607922, 61607919, 61607920

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 20 of 93

CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3332-2018
Recall number
Z-3332-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
25020

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61585927, 61588415, 61595498, 61600756, 61605153, 61609150, 61614790, 61617961, 61620772

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 21 of 93

CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3333-2018
Recall number
Z-3333-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
69750

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61588411, 61589132, 61590240, 61591302, 61591816, 61592013, 61592513, 61594212, 61595169, 61595496, 61596322, 61596323, 61597455, 61597456, 61618678, 61614704, 61618680, 61618681, 61621829, 61621830, 61587111, 61587112

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 22 of 93

CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3334-2018
Recall number
Z-3334-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61593847, 61603311, 61611233, 61589431

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 23 of 93

CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3335-2018
Recall number
Z-3335-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
30530

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61596061, 61600750, 61607496, 61610395, 61616566, 61606145, 61614140, 61618407, 61620795

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 24 of 93

CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3336-2018
Recall number
Z-3336-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
12230

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600330, 61603657, 61613556, 61609152, 61618404, 61621831

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 25 of 93

CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3337-2018
Recall number
Z-3337-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
14520

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61594211, 61597462, 61599654, 61604447, 61616727, 61620761, 61622928

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 26 of 93

CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3338-2018
Recall number
Z-3338-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
17160

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61587117, 61591532, 61598517, 61602586, 61608066, 61612142, 61615752, 61619789

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 27 of 93

CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3339-2018
Recall number
Z-3339-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
3430

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61592016, 61597459, 61605296, 61612425, 61615747, 61620773

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 28 of 93

CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3340-2018
Recall number
Z-3340-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2420

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61581429, 61600731

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 29 of 93

CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3341-2018
Recall number
Z-3341-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61580395

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 30 of 93

CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3342-2018
Recall number
Z-3342-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
3130

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61587790, 61604448

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 31 of 93

CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3343-2018
Recall number
Z-3343-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
93140

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61588414, 61587114, 61590499, 61591305, 61591822, 61592516, 61595497, 61596327, 61597457, 61598516, 61594208, 61600757, 61602063, 61609687, 61611125, 61612545, 61614791, 61615905, 61605299, 61616952, 61618405, 61619350, 61620436, 61622088, 61620983, 61623759, 61622734, 61586767

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 32 of 93

CE17TKFS EPIDURAL TRAY, Material Number 332098 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3344-2018
Recall number
Z-3344-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
24810

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61586632, 61591151, 61594892, 61599653, 61604114, 61608068, 61612419, 61615748, 61619582

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 33 of 93

CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3345-2018
Recall number
Z-3345-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
880

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61596337, 61604211, 61610323

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 34 of 93

CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3346-2018
Recall number
Z-3346-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2740

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61596338, 61600770, 61611456, 61616960

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 35 of 93

CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3347-2018
Recall number
Z-3347-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
340

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61602900

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 36 of 93

CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3348-2018
Recall number
Z-3348-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2090

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61599649

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 37 of 93

CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3349-2018
Recall number
Z-3349-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1350

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61602050

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 38 of 93

CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3350-2018
Recall number
Z-3350-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
10500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61599578, 61602043, 61605370, 61610383, 61613469, 61615920

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 39 of 93

CE18TIN CONT EPIDURAL SET LF, Material Number 332201 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3351-2018
Recall number
Z-3351-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
372

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61614720, 61622724

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 40 of 93

CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3352-2018
Recall number
Z-3352-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
504

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61606898

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 41 of 93

CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3353-2018
Recall number
Z-3353-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
612

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61609098, 61620830, 61592464

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 42 of 93

CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3354-2018
Recall number
Z-3354-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2790

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61597458

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 43 of 93

CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3355-2018
Recall number
Z-3355-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1632

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61604459, 61612341

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 44 of 93

CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3356-2018
Recall number
Z-3356-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
10470

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61594893, 61596328, 61614703

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 45 of 93

CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3357-2018
Recall number
Z-3357-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
8210

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61589440, 61595168, 61602897, 61607727, 61612246, 61616728, 61620762

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 46 of 93

CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3358-2018
Recall number
Z-3358-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
11010

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61588161, 61592517, 61616704, 61618683

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 47 of 93

CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3359-2018
Recall number
Z-3359-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
13890

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598355, 61605294, 61611451, 61616567, 61619580

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 48 of 93

CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3360-2018
Recall number
Z-3360-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
11130

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61592523, 61599135, 61616706, 61616705

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 49 of 93

CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3361-2018
Recall number
Z-3361-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
8380

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600776, 61603834, 61607184, 61607948, 61607947

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 50 of 93

CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3362-2018
Recall number
Z-3362-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
63980

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61595170, 61595613, 61596536, 61598356, 61597084, 61600180, 61617168, 61616702, 61617169, 61616703, 61614599, 61616701, 61616700, 61614596, 61614598, 61619583, 61620763, 61622163, 61621828

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 51 of 93

CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3363-2018
Recall number
Z-3363-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2790

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61597460

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 52 of 93

CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3364-2018
Recall number
Z-3364-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
57820

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61601679, 61600958, 61603831, 61603833, 61607929, 61607931, 61607930, 61607933, 61607937, 61607938, 61607939, 61607934, 61607941, 61607940, 61607935, 61607932

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 53 of 93

CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3365-2018
Recall number
Z-3365-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
24850

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600775, 61607953, 61607952, 61607954, 61607958, 61602694, 61607955, 61607956, 61607957, 61607960, 61612147, 61611469, 61610329

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 54 of 93

CE17TB CONT EPIDURAL TUOHY, Material Number 332224 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3366-2018
Recall number
Z-3366-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
12930

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600785, 61603830, 61607925, 61607926, 61607927, 61608077, 61609165

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 55 of 93

CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3367-2018
Recall number
Z-3367-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1370

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600741

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 56 of 93

CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3368-2018
Recall number
Z-3368-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
3490

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61596062

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 57 of 93

CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3369-2018
Recall number
Z-3369-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61596319, 61599764, 61603312, 61612410, 61616941, 61622918

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 58 of 93

CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3370-2018
Recall number
Z-3370-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61582595, 61599648, 61605283, 61611124, 61614787

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 59 of 93

CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3371-2018
Recall number
Z-3371-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1032

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61589584, 61617132, 61622878

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 60 of 93

CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3372-2018
Recall number
Z-3372-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1980

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61604903, 61618120

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 61 of 93

CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3373-2018
Recall number
Z-3373-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1760

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61599673, 61603318, 61608081, 61616971

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 62 of 93

CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3374-2018
Recall number
Z-3374-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
20280

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61590460, 61594135, 61598572, 61601772, 61605134, 61610126, 61613471, 61615656, 61618348, 61621766

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 63 of 93

CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3375-2018
Recall number
Z-3375-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1980

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61620798, 61583520

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 64 of 93

CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3376-2018
Recall number
Z-3376-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
4150

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61590151, 61599650, 61606619, 61613555, 61619293

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 65 of 93

CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3377-2018
Recall number
Z-3377-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61595499

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 66 of 93

CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3378-2018
Recall number
Z-3378-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2070

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61597444, 61603111, 61618684

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 67 of 93

CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3379-2018
Recall number
Z-3379-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
22280

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61588931, 61589445, 61592524, 61609149, 61598518, 61615365, 61619575, 61620760

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 68 of 93

CLAMP STYLE CATHETER CONNECTOR 20GA- LF, Material Number 332283 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3380-2018
Recall number
Z-3380-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2800

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61602584, 61614773

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 69 of 93

CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3381-2018
Recall number
Z-3381-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
6850

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61604193, 61588390, 61608054, 61618113

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 70 of 93

CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3382-2018
Recall number
Z-3382-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1380

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61599642, 61615741

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 71 of 93

EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3383-2018
Recall number
Z-3383-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
610

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598525, 61610308

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 72 of 93

CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3384-2018
Recall number
Z-3384-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
516

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61611403, 61622439

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 73 of 93

GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3385-2018
Recall number
Z-3385-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1380

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61596329, 61606959

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 74 of 93

GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3386-2018
Recall number
Z-3386-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1020

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61604894, 61608062, 61615893

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 75 of 93

GOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3387-2018
Recall number
Z-3387-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1030

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600734, 61603108

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 76 of 93

GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3388-2018
Recall number
Z-3388-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61608701

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 77 of 93

ES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3389-2018
Recall number
Z-3389-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
8330

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61592507, 61605033, 61609142, 61610302, 61612139, 61613545, 61615728

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 78 of 93

ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3390-2018
Recall number
Z-3390-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1020

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61603106, 61610300, 61619087

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 79 of 93

ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3391-2018
Recall number
Z-3391-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
27710

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61592518, 61600751, 61596330, 61603763, 61608873, 61612141, 61615216, 61619581, 61617800, 61621835

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 80 of 93

ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3392-2018
Recall number
Z-3392-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1490

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61597447, 61605030, 61609257, 61613551, 61618397

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 81 of 93

ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3393-2018
Recall number
Z-3393-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
10320

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61592525, 61596331, 61601859, 61608500, 61611126, 61614295, 61618117, 61621832

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 82 of 93

ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3394-2018
Recall number
Z-3394-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
35680

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61585920, 61588417, 61592015, 61595500, 61600749, 61603117, 61608504, 61611452, 61613685, 61616404, 61618408, 61623650, 61620984

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 83 of 93

NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3395-2018
Recall number
Z-3395-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
4490

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61587099, 61591814, 61603113, 61606091, 61615215, 61618399

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 84 of 93

EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3396-2018
Recall number
Z-3396-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61594132, 61604230, 61618346

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 85 of 93

EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3397-2018
Recall number
Z-3397-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
16400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61595460, 61598575, 61604885, 61608012, 61601770, 61611402, 61614722, 61616889, 61619490, 61623870

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 86 of 93

EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3398-2018
Recall number
Z-3398-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
1000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61609096, 61616890

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 87 of 93

EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3399-2018
Recall number
Z-3399-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
3900

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598699, 61610254

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 88 of 93

EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3400-2018
Recall number
Z-3400-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
10275

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61600403, 61602663, 61608017, 61614723, 61621770

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 89 of 93

EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3401-2018
Recall number
Z-3401-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
2000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61603099

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 90 of 93

EC20C 20G X 100CM CATH CLOSED, Material Number 333540 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3402-2018
Recall number
Z-3402-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
540

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61598576, 61601769, 61604233, 61606631, 61612343, 61616713

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 91 of 93

EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3403-2018
Recall number
Z-3403-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
3050

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61605308, 61608018

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 92 of 93

DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 530112, 530122, 530123, 530124, 530132, 530133, 530134, 530138, 530141, 530142, 530149, 530153, 530155, 530159, 530160, 530164, 530168, 530169, 530171, 530175, 530177, 530179, 530180, 551028, 551266, 551342, 551344, 551394, 551411, 551437, 551474, 551554, 551572, 551624, 551630, 551671, 551672, 551714, 551731, 551732, 551749, 551769, 551771, 551773, 551791, 551810, 551816, 551849, 551859, 551875, 551879, 551889, 551920, 551922, 551938, 551942, 551951, 551971, 551994, 551997, 551998, 552006, 552011, 552020, 552021, 552030, 552031, 552038, 552041, 552047, 552048, 552051, 552076, 552077, 552079, 552083, 552089, 552099, 552100, 552101, 552112, 552113, 552116, 552117, 552119, 552121, 552122, 552123, 552125, 552126, 552133, 552135, 552136, 552147, 552149, 555030, 555040, 555051, 555061, 555063, 555067, 555070, 555076, 555079, 555083, 555091, 555098, 555100, 555110, 555170, 555172, 555175, 555202, 555204, 555215, 555217, 555259, 555271, 555277, 555290, 555296, 555299, 555325, 555340, 555357, 555374, 555421, 555422, 555438, 555449, 555450, 555482, 555483, 555484, 555498, 555525, 555551, 555569, 555578, 555579, 555601, 555647, 555660, 555704, 555706, 555757, 555779, 555854, 555857, 555884, 555904, 555931, 555951, 555987, 570180, 570205, 570222, 570234, 570245, 570246, 570269, 570285 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3404-2018
Recall number
Z-3404-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
296400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61591833, 61599662, 61602691, 61607729, 61616956, 61585954,

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

device · product 93 of 93

BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Z-3405-2018
Recall number
Z-3405-2018
Initiated
July 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
60000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

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

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Code information

Batch: 61606422, 61605072, 61607144, 61618276, 61621554

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.