Recall Z-2766-2026 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corporation
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
| Date | Aug 11, 2026 (initiated Jun 30, 2026) |
| Status | Open, Classified |
| Reason | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/30/2026 via USPS, first class mail. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the affected lot numbers of the product. The product code and lot number can be found on the individual product package and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and replacement product at 888-229-0001 am and 6:00 pm Central Time, Monday through Friday. Please have you |
| Quantity | 24528 units |
| Distribution | US Nationwide. No OUS consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243529 | Solution Administration Sets Baxter Healthcare Corporation, Mar 14, 2025 |