Recall Z-2594-2025 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corporation
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
| Date | Sep 19, 2025 (initiated Aug 8, 2025) |
| Status | Open, Classified |
| Reason | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an Urgent Medical Device Recall notice was issued its consignees on 8/8/2025 via U.S.P.S., first class mail. The notice explained the issue, potential hazard involved and requested the following: Actions to be Taken by Customers 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 package and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and replacement product at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central |
| Quantity | 14400 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203609 | Intravascular Administration Sets Baxter Healthcare Corporation, Sep 30, 2021 |