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FDA (Device enforcement)Recalled 2024-10-21class i

Baxter Healthcare Corporation: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

Hazard

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.

Details from the source

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) Quantity: 4,380 units Lot/code info: UDI/DI 04987456422890, Lot/Serial Numbers: All lots including and manufactured after H20F09053

UPC codes

04987456422890

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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