Z-0374-2025 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
November 27, 2024
Initiation Date
October 21, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
56,304 units

Product Description

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

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 Pattern

Worldwide Distribution (US Nationwide distribution)

Code Information

UDI/DI 00085412489643, Lot/Serial Numbers: All lots including and manufactured after H20A30068