Class I
Medical Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Baxter Healthcare Corporation · October 21, 2024
Reason for Recall
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.
Distribution
Worldwide Distribution (US Nationwide distribution)
States Affected
NATIONWIDE
Quantity Affected
62,394 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0379-2025
Status: ongoing
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