Terminated

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

FDA Recall Z-1576-2015 · Posted 2015-05-04

Recalling FirmB. Braun Medical, Inc.

Recall StatusTerminated

Product CodeBRY

Date Initiated2015-03-27

Date Terminated2017-02-01

Product Quantity5000

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.