Recall Z-2003-2023 ยท OGE Epidural Anesthesia Kit
B. Braun Medical, Inc.
Design Options / Epidural anesthesia kit (10 count carton)
| Date | Jun 23, 2023 (initiated Jun 5, 2023) |
| Status | Open, Classified |
| Reason | Kits were assembled with the incorrect Filter Straw. |
| Root cause | Mixed-up of materials/components |
| Action | 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 |
| Quantity | 3,560 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.