Baxter recalls MiniCap Extended Life PD Transfer Sets with Twist Clamp (R5C4482E) for potential PCB exposure during peritoneal dialysis. Affected units include all lots manufactured after H19K04041.
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.
Baxter is recalling its MiniCap Extended Life PD Transfer Set with Twist Clamp for peritoneal dialysis use due to potential exposure to PCBs. This could pose health risks for patients using the device.
The device may expose users to non-dioxin-like PCBs during peritoneal dialysis, which are chemicals linked to health risks. This risk occurs when the device is used in the dialysis process.
Patients using peritoneal dialysis with this specific Baxter device are most at risk. The recall affects all units manufactured after H19K0:04041.
Check for the part number R5C4482E on the device. The device was manufactured after H19K04041 and includes all lots with the UDI/DI 05413760375861.
Look for part number R5C4482E and UDI/DI 05413760375861 on the device label.
The recall states potential exposure to PCBs during peritoneal dialysis, but no specific safety instructions are provided.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected model.
Check for part number R5C4482E and UDI/DI 05413760375861 on the device label. Affected units were manufactured after H19K04041.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0378-2025 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0378-2025 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.