Baxter Recalls Revaclear 300 Dialyzers Due to Potential Foreign Matter
Baxter Healthcare is recalling Revaclear 300 Capillary Dialyzers because of the potential presence of particular matter in the header caps of ten lots.
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 the hazard involves potential foreign matter in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Baxter Healthcare Corporation is recalling the Revaclear Capillary Dialyzer 300 (Product Code 114745L). The recall involves 101,976 devices distributed nationwide. The specific lots affected are C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, and C419126401.
The recall was initiated due to the potential presence of particular matter in the header caps of these dialyzers. The source text does not specify the nature of the matter or report any illnesses or injuries associated with the use of these devices.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to Baxter Healthcare Corporation in accordance with their recall instructions.
The recalled product
- Product
- Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 101,976
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 (11)
- UDI 07332414123055
- Lot Numbers: C419124901
- C419125001
- C419125101
- C419125201
- C419125401
- C419125501
- C419125601
- C419125801
- C419126001
- C419126401
Distribution
Distributed nationwide across the United States.
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