Device product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Z-0561-2025
Product summary
- Event
- Event 95524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31248 units
- Official record key
device-enforcement:Z-0561-2025
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 00085412476261, Lot/Serial Numbers: H23J13063, H23J26081, H24B18059, H24B19065, H24B19099, H24B20071, H24C18065, H24E22062, H24F11048
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.