Device product
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Z-1145-2018
Product summary
- Event
- Event 79426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-1145-2018
Official wording
Reason: 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Code information: Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932
Distribution pattern: United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Derived failure modes
-
Unknown
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.