Device product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Z-0560-2025
Product summary
- Event
- Event 95524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22392 units
- Official record key
device-enforcement:Z-0560-2025
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 00085412489643, Lot/Serial Numbers: H24C19063, H24G22092, H24G25061
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.