FDA Enforcement
Class II
Ongoing
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Recall: Z-1010-2025
·
Reported January 29, 2025
Enforcement
- Recall Number
- Z-1010-2025
- Event ID
- 95929
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 29, 2025
- Initiation Date
- December 20, 2024
- Classification Date
- January 22, 2025
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States
Description
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Reason
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Code Info
UDI/DI 00085412676647, Lot Numbers: DR24C15109 (exp. 3/16/2026)
Distribution
US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.