FDA Device recall Z-0375-2025
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S
- FDA Device
- Class I
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class I recall of Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S by Baxter Healthcare, citing 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 polychl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0375-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-21 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; 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.
Identifiers
| code_info | UDI/DI 00085412476261, Lot/Serial Numbers: All lots including and manufactured after H19J11055 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0375-2025%22
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