FDAClass IIMay 13, 2015

CONTIPLEX Continuous Peripheral Nerve Block Tray recall: Sterility Concern

CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural…

Why was CONTIPLEX Continuous Peripheral Nerve Block Tray recalled?

There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product codes: 331706 332128 331756 551474 551572 551727 551749 551769 551771 551773 551858 551889 551922 551942 552011 555098 555170 555215 555217 555325 555422 530132 530155 551273 551845 551970 551992 555212 555876 560123 560473 530035 530068 333194 333192 332211 332282 332079 332097 332086 332292 Batch Numbers: 61415053 61416382 61416362 61415022 61414464 61415024 61416390 61415028 61415921 61415924 61415023 61414468 61415044 61415051 61415037 61411483 61418020 61418077 61416399 61415041 61416385 61414419 61414589 61415712 61412398 61413393 61414485 61414481 61414591 61417210 61412387 61415001 61415013 61418035 61414411 61413390 61416395 61414492 61415040 61414417 61411528 61415708 expiration dates: 7/31116 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 6/30/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 1/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 9/30/16 7/31/16 6/30/16 6/30/16 3/31/17 2/28/17 7/31/16 7/31/16 7/31/16 1/31/18 7/31/16 7/31/16 6/30/16 7/31/16 2/28/17 6/30/16 1/31/17

Product
CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural…
Recalling firm
B. Braun Medical, Inc.
Quantity
5000
Distribution
Nationwide Distribution.
Recall date
May 13, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls