FDA-Device2018-03-28Class II
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
Merit Medical Systems, Inc.
Hazard
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
Sold states
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Affected count
30
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1143-2018Don't want to check this manually?
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