Design Options / Epidural anesthesia kit (10 count carton)
This recall is currently active, issued June 23, 2023. It was issued by B Braun Medical Inc.
- Company
- B Braun Medical Inc
- Recall Initiated
- June 5, 2023
- Posted
- June 23, 2023
- Recall Number
- Z-2003-2023
- Quantity
- 3,560 units
- Firm Location
- Allentown, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Kits were assembled with the incorrect Filter Straw.
Distribution
US Nationwide distribution.
Lot / Code Info
Model No. 552177, 552155, 552179, 552116; GTIN: 04046955596102, 04046955214440, 04046955596140, 04046964950254; Lot No. 0061853751, 0061854949, 0061855598, 0061855133.
Root Cause
Mixed-up of materials/components
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.