FDA-Device2018-03-28Class II
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Merit Medical Systems, Inc.
Hazard
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Sold states
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Affected count
8
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2018Don't want to check this manually?
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