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 polychlorinated biphenyls found in similar devices.
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 High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4482EJ). This product is used for peritoneal dialysis. The recall affects 56,304 units distributed worldwide, including nationwide distribution in the United States.
The recall is being conducted because 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). These chemicals have been identified as a potential risk when using certain peritoneal and hemodialysis devices.
The affected units include all lots manufactured after H20A30068. The Unique Device Identifier (UDI/DI) is 00085412489643. Patients and healthcare providers should consult the FDA recall notice for specific instructions on how to proceed with the use of these devices.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 56,304
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 00085412489643
- Lot/Serial Numbers: All lots including and manufactured after H20A30068
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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