Design Options / Epidural anesthesia kit (10 count carton)

FDA device recall Z-2003-2023 · posted 2023-06-23 · Open, Classified

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

Kits were assembled with the incorrect Filter Straw.

Action taken

Customers received a recall notification dated 06/05/2023 by mail notifying them that affected lots of Epidural Kits were inadvertently assembled with the incorrect Filter Straw. The recall notification asks customers to determine if any affected devices are in inventory and subsequently quarantine any identified product, return the Product Recall Acknowledgement Form notating any affected devices currently in quarantine, and return the form by fax to 610-849-1197 or by email to PA_QualityAssurance.BBMUS_Service@bbraunusa.com. Coordination of product return for provision of credit/replacement will commence upon return of the form. If product has been further distributed the firm asks that the recall notification be forwarded to those consignees down to the consumer level. Customers with any questions can direct them to BBMI's Postmarket Surveillance Department at 1-883-425-1464.

Root cause

Mixed-up of materials/components

Status

Open, Classified

Product code

OGE

Quantity affected

3,560 units

Distribution

US Nationwide distribution.

Date initiated

2023-06-05

Date posted

2023-06-23

Location

Allentown, PA