Z-2594-2025 Class II Ongoing
FDA device recall Z-2594-2025 was initiated by Baxter Healthcare Corporation on Aug 8, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 14400 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 1, 2025
- Initiation Date
- Aug 8, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14400 units
Product description
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 pattern
US Nationwide distribution.
Code information
UDI/DI 00085412048994, Lot Number R24I20079, Exp. 9/21/2026
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2594-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026