Device product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Z-0562-2025
Product summary
- Event
- Event 95524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 62,718
- Official record key
device-enforcement:Z-0562-2025
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: H23J10051, H23J23062, H23K20066, H24C08033, H24E16080, H24F12046, H24F17045, H24G02045, H24I02090
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.