FDA Medical devices recall ·
Baxter Clearlink System Solution Set with Duo-Vent Spike recall
- Recall number
- Z-1010-2025
- Date
- (initiated December 20, 2024)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Why was it recalled?
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Florida Massachusetts Minnesota Missouri South Carolina Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1010-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.