FDA recall Z-1010-2025

Baxter Healthcare Corporation · Class II · device

Product

Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

Reason for recall

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

Distribution

US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.

Key facts

Status
Ongoing
Initiation date
2024-12-20
Report date
2025-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2025