Medical device recalls High risk

Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis

Recall date
October 21, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0382-2025
FDA classification
Class I
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Worldwide Distribution (US Nationwide distribution)

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis

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