Device product
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
Z-2594-2025
Product summary
- Event
- Event 97447
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14400 units
- Official record key
device-enforcement:Z-2594-2025
Official wording
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.
Code information: UDI/DI 00085412048994, Lot Number R24I20079, Exp. 9/21/2026
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.