Baxter Revaclear 300 Dialyzers Recalled for Polyurethane Displacement
Baxter is recalling approximately 14 million units of Revaclear 300 dialyzers worldwide due to polyurethane displacement that could cause blood leaks. No injuries have been reported.
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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard—polyurethane displacement potentially causing blood leaks—represents a risk of harm in a critical medical device, but no actual patient injuries have been documented.
Plain-English summary
Baxter Healthcare Corporation is recalling Revaclear 300 dialyzers due to polyurethane displacement in the device that could result in blood leaks. The dialyzers are used to treat patients with chronic and acute renal failure through hemodialysis.
Approximately 14 million units are affected across worldwide distribution, including the United States and numerous countries across Europe, the Middle East, Africa, Asia-Pacific, and the Americas. The affected lot numbers range from C419128801 to C422128401.
No illnesses or injuries related to this defect have been reported. Patients currently using these dialyzers should contact their healthcare provider or Baxter for guidance on device replacement and alternative treatment options. Healthcare facilities should verify the lot numbers of dialyzers in use and follow their medical team's instructions regarding continued use.
The recalled product
- Product
- Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 14,053,824
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 (3)
- UDI-DI: 07332414123055
- Product Code: 114745L
- All lot numbers from C419128801-C422128401
Distribution
Distributed nationwide across the United States.
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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