Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture
Baxter Healthcare is recalling Revaclear 300 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect (ruptured fibers) that poses a risk of significant injury (blood leak) during a critical medical procedure.
Plain-English summary
Baxter Healthcare Corporation is recalling approximately 1,249,272 units of REVACLEAR 300 Dialyzers (Product Code 114745L). 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. This defect may lead to a blood leak during treatment. The affected units were distributed nationwide in the United States and internationally to Canada and Bermuda.
Healthcare providers and patients should stop using the affected dialyzers and contact Baxter Healthcare Corporation for further instructions. The recall covers specific lot numbers listed in the official FDA notice.
The recalled product
- Product
- REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 1,249,272
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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