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.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
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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