PlainRecalls
FDA Devices Critical Class I Ongoing

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

Reported: November 27, 2024 Initiated: October 21, 2024 #Z-0373-2025

Product Description

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

Reason for Recall

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.

Details

Units Affected
2,706,558 units
Distribution
Worldwide Distribution (US Nationwide distribution)
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis. Recalled by Baxter Healthcare Corporation. Units affected: 2,706,558 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 27, 2024. Severity: Critical. Recall number: Z-0373-2025.