Recall Z-3144-2024 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
| Date | Sep 13, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| Reason | Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process. |
| Root cause | Process change control |
| Action | An URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated 8/6/24 was sent to customers. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review the Medical Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons are informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the consumer level. 2. Determine your current inventory of the affected items within in |
| Quantity | 19050 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |