Baxter Clearlink system solution sets recalled for clamp defect
Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a functional defect in a product used for infusion therapy. The defect poses a risk of harm to patient care if the defective units are used, but no injuries have been reported, placing this in the risk-of-harm category without documented adverse events.
Plain-English summary
Baxter Healthcare Corporation is recalling specific lots of Clearlink System Solution Sets with Duo-Vent Spike (REF 2R8538) due to a manufacturing defect involving the side clamps.
The affected solution sets contain inverted clamps that prevent the tubing from functioning properly, making the sets unusable. The defect affects lot number DR24C15109 with an expiration date of 3/16/2026.
The recalled units have been distributed nationwide to healthcare facilities in Minnesota, Missouri, Virginia, Texas, California, Massachusetts, Florida, and South Carolina. Healthcare providers who have received these solution sets should verify their current inventory against the affected lot number.
The recalled product
- Product
- Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Set
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00085412676647
- Lot Numbers: DR24C15109 (exp. 3/16/2026)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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