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.
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: 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
- Affected units
- 62,394
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.
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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