Perifix / Epidural anesthesia set, medicated
This recall is currently active, issued September 21, 2023. It was issued by B Braun Medical Inc.
- Company
- B Braun Medical Inc
- Recall Initiated
- July 31, 2023
- Posted
- September 21, 2023
- Recall Number
- Z-2627-2023
- Quantity
- 3440 units
- Firm Location
- Allentown, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Product may be mislabeled with an incorrect lid stock label.
Distribution
US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
Lot / Code Info
UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025
Root Cause
Process control
Action Taken
An "URGENT MEDICAL DEVICE RECALL" letter dated 8/14/23 was issued to affected customers on 08/14/2023. The letter described the product, problem and actions to be taken. The Customers are instructed to review inventory, cease use and quarantine impacted product and complete and return the Product Recall Acknowledgement Form back to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610)849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraunusa.com. B. Braun Medical will facilitate return of impacted product. If you have any questions, contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.