Baxter Recalls Revaclear 400 Dialyzers Due to Potential Fiber Rupture
Baxter Healthcare is recalling Revaclear 400 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (potential blood leak) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling 65,403 units of REVACLEAR 400 Dialyzers (Product Code 114746L). The recall affects specific lots identified by UDI 07332414124076 and lot numbers C419205101, C419205201, and C419205301. These medical devices are indicated for the treatment of chronic and acute renal failure by hemodialysis.
The recall was initiated due to a potential presence of ruptured dialyzer fibers, which may lead to a blood leak during treatment. The affected products were distributed nationwide in the United States and internationally to Canada and Bermuda.
Healthcare providers and patients should stop using the affected dialyzers immediately. Baxter Healthcare is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 65,403
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 (1)
- UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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