FDA Device Recall Z-0377-2025

Baxter Healthcare Corporation · Deerfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis

Lot / serial / GTIN: UDI/DI 00085412007748, Lot/Serial Numbers: All lots including and manufactured after H19J22078

Quantity: 410,862 units

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.

Recall record

Recall number: Z-0377-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide Distribution (US Nationwide distribution)
Recall initiated: 2024-10-21
Classified by FDA Center: 2024-11-20
FDA published: 2024-11-27
Recalling firm: Baxter Healthcare Corporation
Firm location: Deerfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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