Device product
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Z-0569-2025
Product summary
- Event
- Event 95524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13376 units
- Official record key
device-enforcement:Z-0569-2025
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 0085412150703, Lot/Serial Numbers: H23J02025, H23L04043, H23L05057, H23L05073, H24A29041, H24C01061, H24E13061, H24G15062
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.