Device product

Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

Z-1144-2018

September 20, 2017

Class II

Product summary

Firm: Merit Medical Systems, Inc.
Event: Event 79426
Status: Terminated
Classification: Class II
Quantity: 44
Official record key: device-enforcement:Z-1144-2018

Official wording

Reason: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.

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

Distribution pattern: United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.