The Recall Desk
SevereFDA (Devices)·Z-0377-2025·Announced 2024-11-27

Baxter Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I, which mandates a minimum severity score of 4 per FDA regulatory standards. The potential for PCB exposure in a critical medical dialysis device warrants Severe classification.

Plain-English summary

Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number R5C4482) used in peritoneal dialysis treatment. The recall affects approximately 410,862 units distributed nationwide and worldwide, with all lots manufactured on or after H19J22078 being affected.

The recall was initiated due to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and non-dioxin-like polychlorinated biphenyls (PCBs) when using the device. Baxter became aware of this issue through recalls by other manufacturers of peritoneal dialysis and hemodialysis devices.

Patients currently using affected lots should contact their healthcare provider or Baxter for guidance on continued use and potential replacement of the device.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Peritoneal Dialysis Equipment
Hazard
Affected units
410,862

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00085412007748
  • Lot/Serial Numbers: All lots including and manufactured after H19J22078

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

Same manufacturer · Baxter Healthcare Corporation

See all →

Same hazard · pcb exposure

See all →