The Recall Desk
SevereFDA (Devices)·Z-0373-2025·Announced 2024-11-27

Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

Baxter Healthcare recalls peritoneal dialysis transfer sets (Part Number 5C4482) due to potential contamination with polychlorinated biphenyls (PCBs). The recall affects 2.7 million units distributed worldwide.

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: FDA Class I classification requires a minimum severity score of 4. Although no illnesses or deaths have been reported, the FDA's own highest-tier classification for medical device recalls indicates a serious adverse health consequence is possible.

Plain-English summary

Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4482), used for peritoneal dialysis treatment. The recall affects approximately 2.7 million units distributed worldwide, including the United States. All lots manufactured after H19I26088 are included in this FDA Class I recall.

The recall is based on Baxter's awareness of recalls by other manufacturers related to a potential risk of exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs) and non-dioxin-like polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. This is the agency's highest classification, indicating a potentially serious health hazard.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Peritoneal Dialysis Equipment
Hazard
Affected units
2,706,558

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 00085412007731
  • Lot/Serial Numbers: All lots including and manufactured after H19I26088

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

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Same hazard · pcb contamination

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