Baxter peritoneal dialysis transfer set recalled for PCB exposure risk
Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.
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 FDA has classified this as a Class I recall, establishing a minimum severity level of 4 per the severity rubric. No illnesses or injuries are reported in the source material.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4482S), a peritoneal dialysis device. The U.S. Food and Drug Administration has designated this a Class I recall.
The device is being recalled because of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and non-dioxin-like polychlorinated biphenyls (PCBs) when used in peritoneal dialysis. Polychlorinated biphenyls are industrial chemicals known to persist in the environment and accumulate in body tissues.
This recall affects 151,020 units distributed worldwide, including throughout the United States. The affected devices were manufactured after lot/serial number H19J11055 and are identified by UDI/DI 00085412476261.
Patients and healthcare providers using this transfer set should contact Baxter Healthcare Corporation or consult with their healthcare provider for guidance on obtaining replacement devices. The FDA is monitoring this recall.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Dialysis
- Hazard
- Affected units
- 151,020
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 00085412476261
- Lot/Serial Numbers: All lots including and manufactured after H19J11055
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.
See all 10 products in this recall →Related recalls
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