Class 2 Device Recall Various B. Braun pain control convenience trays

• Date Initiated by Firm: March 27, 2015
• Date Posted: May 04, 2015
• Recall Status: Terminated on February 01, 2017
• Recall Number: Z-1576-2015
• Recall Event ID: 70870
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn; Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural; Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural; Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ; PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous; Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; ; ; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s).; ; ; Custom Epidural and Anesthesia Tray
• Code Information: 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
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Customer Support; 610-266-0500
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: BBMI provided a recall notification letter, dated March 27, 2015, to distributors and end users in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. All customers were provided with instructions for disposition of suspect product in their inventory. Distributors were reminded of their responsibility in executing the recall. Returned product will be sent to the BBMI Distribution Center in Breiningsville, PA.
• Quantity in Commerce: 5000
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.