FDA recall Z-2594-2025

Baxter Healthcare Corporation · Class II · 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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-08-08
Report date
2025-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2594-2025