FDA recall Z-1145-2018

Merit Medical Systems, Inc. · Class II · device

Product

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

United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

Key facts

Status
Terminated
Initiation date
2017-09-20
Report date
2018-03-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2018