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Recall Observatory FDA recall evidence

Device product

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis

Z-0378-2025

October 21, 2024

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95525
Status
Ongoing
Classification
Class I
Quantity
58,680 units
Official record key
device-enforcement:Z-0378-2025

Official wording

Reason: 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.

Code information: UDI/DI 05413760375861, Lot/Serial Numbers: All lots including and manufactured after H19K04041

Distribution pattern: Worldwide Distribution (US Nationwide distribution)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.