Baxter AK 98 Dialysis Machine Recalled for Potential Chemical Exposure
Baxter is recalling AK 98 Dialysis Machines due to potential exposure to polychlorinated biphenyl acids and polychlorinated biphenyls.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal…"
Plain-English summary
Baxter Healthcare Corporation is recalling the AK 98 Dialysis Machine, Hemodialysis Delivery System (Product Code 955607). The recall involves 1,100 units with UDI/DI 07332414124519 and serials with a runtime of less than 500 hours. These units were distributed nationwide in the US and worldwide.
The recall is being conducted because Baxter is aware of recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source text does not specify if illnesses or injuries have been reported for this specific product.
Consumers and healthcare providers should contact Baxter Healthcare Corporation for further instructions on how to handle the recalled equipment. As of February 2025, the firm name is Vantive.
The recalled product
- Product
- Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,100
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 (2)
- UDI/DI 07332414124519
- All serials with runtime less than 500 hours
Distribution
Distributed nationwide across the United States.
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