Recall Z-2627-2023 ยท OGE Epidural Anesthesia Kit
B. Braun Medical, Inc.
Perifix / Epidural anesthesia set, medicated
| Date | Sep 21, 2023 (initiated Jul 31, 2023) |
| Status | Open, Classified |
| Reason | Product may be mislabeled with an incorrect lid stock label. |
| Root cause | Process control |
| Action | 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 Sur |
| Quantity | 3440 units |
| Distribution | US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.