Device product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Z-0559-2025
Product summary
- Event
- Event 95524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 409464 units
- Official record key
device-enforcement:Z-0559-2025
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 00085412007731, Lot/Serial Numbers: H23J16074, H23K01082, H23K06107, H23K09093, H23K28051, H23K30081, H23L07053, H23L13051, H23L27093, H24A03061, H24A09035, H24A11064, H24A29132, H24B02038, H24B12086, H24B21079, H24B28090, H24B29072, H24B29098, H24C21093, H24C27090, H24D08064, H24D11050, H24D17040, H24D22081, H24D26058, H24D30076, H24E06065, H24E23037, H24E28051, H24F03045, H24F05065, H24F17086, H24F24033, H24F27036, H24H05061, H24H08032, H24H13040, H24H16043, H24H22025
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.