Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled for inverted clamps
Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US 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: FDA Class II medical device recall where the defect renders the device unusable, creating a risk of harm to patients requiring infusion therapy. However, no illnesses or injuries have been reported, and the hazard is stated as potential rather than confirmed, placing this at the maximum of 3 per the rubric for theoretical risks.
Plain-English summary
Baxter Healthcare Corporation is recalling specific lots of the Continu-Flo Solution Set with Duo-Vent Spike (REF UC8519). The solution sets have the potential for inverted side clamps, which renders the tubing unusable and prevents proper use of the device.
Affected units include Lot Number DR24B21017 (expiration 02/28/2026), identified by UDI/DI 00085412486512. Distribution was nationwide, including Minnesota, Missouri, Virginia, Texas, California, Massachusetts, Florida, and South Carolina.
No illnesses or injuries related to this defect have been reported. Healthcare providers and patients using affected solution sets should contact Baxter Healthcare Corporation with questions or to report any related incidents.
The recalled product
- Product
- Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Set
- Hazard
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 00085412486512
- Lot Numbers: DR24B21017 (exp. 02/28/2026)
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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