Device product

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis

Z-0565-2025

October 23, 2024

Class II

Product summary

Firm: Baxter Healthcare Corporation
Event: Event 95524
Status: Ongoing
Classification: Class II
Quantity: 8,394 units
Official record key: device-enforcement:Z-0565-2025

Official wording

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.

Code information: UDI/DI 00085412008783, Lot/Serial Numbers: H23J30067

Distribution pattern: Worldwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.