Device product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Z-0376-2025
Product summary
- Event
- Event 95525
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 319,308 units
- Official record key
device-enforcement:Z-0376-2025
Official wording
Reason: 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.
Code information: UDI/DI 00085412007748, Lot/Serial Numbers: All lots manufactured between and including H19J14422 and H24F17045
Distribution pattern: Worldwide Distribution (US Nationwide distribution)
Derived failure modes
-
Unknown
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.