Device product
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Z-1009-2025
Product summary
- Event
- Event 95929
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1009-2025
Official wording
Reason: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Code information: UDI/DI 00085412676630, Lot Numbers: DR24C22079 (exp.3/247/2026), DR24H23086 (exp. 8/26/2026)
Distribution pattern: US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.
Derived failure modes
-
Unknown
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.