Recall Z-1010-2025 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corporation
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
| Date | Jan 22, 2025 (initiated Dec 20, 2024) |
| Status | Open, Classified |
| Reason | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. |
| Root cause | Process control |
| Action | Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/20/2024. The notice explained the problem with the device, hazard involved and requested the following: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. The product code and lot number can be found on the individual product and shipping carton. 2. Contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday to arrange for return and credit. Please have your Baxter 8-digit ship-to account |
| Distribution | US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180739 | Clearlink System Solution Set Baxter Healthcare Corporation, May 28, 2019 |