Baxter MiniCap PD Transfer Set Recalled for Potential PCB Exposure
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 5C4483. This product is used in peritoneal dialysis. The recall involves 319,308 units distributed worldwide, including nationwide distribution in the US.
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) when using certain peritoneal dialysis and hemodialysis devices. The affected units include all lots manufactured between and including H19J14422 and H24F17045.
Patients and healthcare providers using this product should contact Baxter Healthcare Corporation for further instructions on how to proceed. The source text does not specify specific consumer actions beyond the recall notice itself.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 319,308
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 (1)
- UDI/DI 00085412007748
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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