Recall Z-1291-2024 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corporation
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
| Date | Mar 14, 2024 (initiated Feb 8, 2024) |
| Status | Open, Classified |
| Reason | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an Urgent Medical Device Recall notice to its consignees on 02/08/2024 via US mail. The notice explained the problem, hazard involved, and requested the following actions be taken: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number |
| Quantity | 26,592 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180739 | Clearlink System Solution Set Baxter Healthcare Corporation, May 28, 2019 |