Home / Recalls / Baxter Healthcare Corporation / Z-0377-2025

Z-0377-2025 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
410,862 units

Product Description

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; 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 00085412007748, Lot/Serial Numbers: All lots including and manufactured after H19J22078

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  • D-0296-2026 Class II — Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte (December 22, 2025)
  • Z-1121-2026 Class II — SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 (November 28, 2025)
  • Z-0847-2026 Class II — Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product r (October 28, 2025)
  • Z-0233-2026 Class II — Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Pl (September 17, 2025)
  • Z-0203-2026 Class II — CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and C (August 29, 2025)
  • Z-0195-2026 Class II — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CL (August 29, 2025)
  • Z-0190-2026 Class II — CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drop (August 29, 2025)