Revaclear 400 Dialyzers Recalled for Polyurethane Displacement Risk
Baxter Healthcare is recalling Revaclear 400 dialyzers due to reports of polyurethane displacement, which could result in blood leaks during dialysis treatment. The recall affects over 6 million units distributed 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 Class II medical device recall involving a manufacturing defect with potential for patient harm. No illnesses or injuries have been reported in the source material. The risk of blood leaks in dialyzer equipment represents significant potential harm to dialysis patients, placing this recall in the High severity category.
Plain-English summary
Baxter Healthcare Corporation is recalling Revaclear 400 dialyzers used for hemodialysis treatment of chronic and acute renal failure. The recall was initiated due to reports of polyurethane displacement in the dialyzer, which could manifest as a blood leak during treatment.
This recall affects approximately 6.3 million units distributed worldwide, including across the United States, Canada, and numerous international markets. The affected dialyzers include two product codes: 114746L (lot numbers C421221401–C422228501) and 114746M (lot numbers C422218601–C422219901).
Patients currently using Revaclear 400 dialyzers should contact their healthcare provider or dialysis center immediately to determine if their unit is affected by this recall. Healthcare providers should verify lot numbers and follow their facility's recall procedures.
The recalled product
- Product
- Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 6,338,280
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 (5)
- a. UDI-DI: 07332414124076
- Product Code: 114746L
- All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209
- Product Code: 114746M
- All lot numbers from C422218601-C422219901
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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