FDA Enforcement
Class I
Ongoing
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Recall: Z-0374-2025
·
Reported November 27, 2024
Enforcement
- Recall Number
- Z-0374-2025
- Event ID
- 95525
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2024
- Initiation Date
- October 21, 2024
- Classification Date
- November 20, 2024
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
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 Info
UDI/DI 00085412489643, Lot/Serial Numbers: All lots including and manufactured after H20A30068
Distribution
Worldwide Distribution (US Nationwide distribution)
Quantity
56,304 units