CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anest

FDA device recall Z-1576-2015 · posted 2015-05-04 · Terminated

Recall details

Recalling firm

B. Braun Medical, Inc.

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.

Action taken

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

Status

Terminated

Product code

BRY

Quantity affected

5000

Distribution

Nationwide Distribution.

Date initiated

2015-03-27

Date posted

2015-05-04

Date terminated

2017-02-01

Location

Allentown, PA