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
- Hazard
- pcb-contamination
- chemical-exposure
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.
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