Baxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (chemical exposure) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484. This product is used for peritoneal dialysis. The recall involves 18,426 units distributed worldwide, including nationwide distribution in the United States.
The recall is being conducted because Baxter is aware of recalls by other manufacturers regarding the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs). These chemicals may be present when using certain peritoneal and hemodialysis devices.
The affected units include all lots manufactured after H20B11116. The Unique Device Identifier (UDI/DI) is 00085412050768. Patients and healthcare providers should consult their healthcare providers for guidance on alternative products or further instructions regarding this recall.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 18,426
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 00085412050768
- Lot/Serial Numbers: All lots including and manufactured after H20B11116
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.
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