FDA Device recall Z-0563-2025
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482 by Baxter Healthcare, citing there has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0563-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-23 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Reason
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Identifiers
| code_info | UDI/DI 00085412007748, Lot/Serial Numbers: H23K15033, H23K17088, H23L15049, H23L20049, H24A17046, H24A23069, H24C13090, H24D15036, H24C29493 |
|---|
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-0563-2025%22
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