FDA Medical devices recall ·
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0327-2025
- Date
- (initiated October 16, 2024)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1100 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Why was it recalled?
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 dialysis and hemodialysis devices.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 07332414124519, All serials with runtime less than 500 hours
Distribution
US Nationwide distribution and worldwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0327-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.