Baxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
Baxter Healthcare is recalling 22,656 Revaclear MAX dialyzers because of potential particulate matter on the blood side of the device.
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 involves a high-risk medical device where a defect (particulate matter) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corp. is recalling 22,656 units of the GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634. The recall is due to the potential presence of particulate matter on the blood side of the dialyzer.
The Revaclear Max dialyzer is a single-use medical device used for the treatment of chronic and acute renal failure by hemodialysis. The affected units were distributed worldwide, including the United States, Canada, and Mexico.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any specific illnesses or injuries associated with the particulate matter.
The recalled product
- Product
- GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 22,656
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)
- C416201601
Distribution
Distributed nationwide across the United States.
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