Baxter MiniCap Peritoneal Dialysis Transfer Set recalled for potential PCB exposure
Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult their healthcare provider.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a score of at least 4 per agency rules. Although no illnesses, deaths, or confirmed exposures are reported, the severity of the potential hazard and regulatory classification support a Severe rating.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number R5C4482E), a medical device used in peritoneal dialysis procedures. Approximately 58,680 units have been distributed worldwide, including throughout the United States.
The device is being recalled due to a potential risk of exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs) and non-dioxin-like polychlorinated biphenyls (PCBs).
Patients using peritoneal dialysis with this transfer set may be at risk. Affected units are identified by UDI/DI 05413760375861 and lot/serial numbers manufactured after H19K04041.
Patients should immediately stop using this device if they possess an affected unit and contact their healthcare provider for alternative dialysis options. Report any adverse events to the FDA's MedWatch program.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 58,680
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 05413760375861
- Lot/Serial Numbers: All lots including and manufactured after H19K04041
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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