Z-1144-2018 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
- 44
Product Description
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Reason for Recall
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
Distribution Pattern
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Code Information
Lot #: a) H1190448, Exp 7/31/2020, UDI (01)00884450328620(17)200731(10)H1190448; b) H1193585, Exp 5/30/2019, UDI (01)00884450328620(17)190530(10)H1193585