B. Braun Medical, Inc. Design Options / Epidural anesthesia kit (10 count carton) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Kits were assembled with the incorrect Filter Straw.

Recommended Action

Per FDA guidance

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.