Z-1145-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- September 20, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Reason for Recall
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Distribution Pattern
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Code Information
Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932