Baxter recalls MiniCap Extended Life PD Transfer Sets with Twist Clamp (Part R5C4484) for potential PCB exposure during peritoneal dialysis. Affected units include all lots manufactured after H20B11116.
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 to patients using the device. The recall affects all units manufactured after a specific date.
The device may expose users to non-dioxin-like PCBs during peritoneal dialysis. These chemicals are known to be harmful, though the exact risk level isn't specified in the recall notice.
Patients using peritoneal dialysis with this specific Baxter device are most at risk. The recall applies to all units manufactured after H20B11116.
Check for the part number R5C4484 on the device. Affected units include all lots manufactured after H20B11116 and have the UDI/DI 00085412050768.
Look for the part number R5C4484 and UDI/DI 00085412050768 on the device.
The recall states there is a potential risk of exposure to PCBs, but it does not specify if the device is safe to use without action.
The recall does not provide specific action steps for affected users.
Check for the part number R5C4484 and UDI/DI 00085412050768. Affected units include all lots manufactured after H20B11116.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0380-2025 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0380-2025 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.