Baxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk
Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I medical device recall is classified as Severe (score 4) per the rubric requirement that Class I recalls never score below 4. No reported deaths or illnesses are documented in the source material.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number R5C4483), a medical device used in peritoneal dialysis treatment. The recall addresses a potential risk of exposure to non-dioxin-like polychlorinated biphenyls (PCBs) and polychlorinated biphenyl acids (PCBAs) in these transfer sets. This issue was identified following awareness of similar recalls issued by other manufacturers of peritoneal dialysis and hemodialysis devices.
Approximately 62,394 units have been distributed worldwide, including throughout the United States. The affected products include all lots manufactured on or after lot number H19J21062. The product's Unique Device Identifier is 00085412008783. Patients and healthcare providers can identify potentially affected transfer sets by checking the lot number on the packaging.
This is a Class I medical device recall.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- chemical-exposure
- pcb-exposure
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 00085412008783
- Lot/Serial Numbers: All lots including and manufactured after H19J21062
Distribution
Distributed nationwide across the United States.
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