Perifix / Epidural anesthesia set, medicated
FDA device recall Z-2627-2023 · posted 2023-09-21 · Open, Classified
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Product may be mislabeled with an incorrect lid stock label.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OGE
- Quantity affected
- 3440 units
- Distribution
- US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
- Date initiated
- 2023-07-31
- Date posted
- 2023-09-21
- Location
- Allentown, PA
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