Device product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Z-0563-2025
Product summary
- Event
- Event 95524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 83,448 units
- Official record key
device-enforcement:Z-0563-2025
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 00085412007748, Lot/Serial Numbers: H23K15033, H23K17088, H23L15049, H23L20049, H24A17046, H24A23069, H24C13090, H24D15036, H24C29493
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.