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
- Hazard
- pcb-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 00085412007748
- Lot/Serial Numbers: All lots including and manufactured after H19J22078
Distribution
Distributed nationwide across the United States.
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