Baxter Revaclear 400 Dialyzers Recalled for Polyurethane Displacement
Baxter Healthcare is recalling Revaclear 400 dialyzers because polyurethane displacement may cause blood leaks during dialysis treatment. Approximately 1.14 million units are affected worldwide.
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 FDA Class II recall for a medical device with a structural defect that creates a risk of blood leaks during hemodialysis treatment. No illnesses or injuries have been reported in the source text. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling Revaclear 400 dialyzers, which are used for hemodialysis treatment of chronic and acute kidney failure. These dialyzers are subject to polyurethane displacement that may be identified as blood leaks during use.
The recall affects approximately 1,140,096 units distributed worldwide. No units were distributed in the United States. The affected dialyzers are identified by lot numbers ranging from C422202401 through C422227201.
Healthcare providers and patients currently using these dialyzers should contact Baxter Healthcare Corporation for information about this recall.
The recalled product
- Product
- Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,140,096
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)
- No distribution in the USA. Product Code: 114749M
- All lot numbers from C422202401 C422227201
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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