FDA-Device2024-11-27Class I

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis

Baxter Healthcare Corporation
Hazard

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.

Sold states
Worldwide Distribution (US Nationwide distribution)
Affected count
319,308 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0376-2025

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