Merit Medical Systems, Inc. recalls Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
- Recall date
- September 20, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1143-2018
- FDA classification
- Class II
- Brand / firm
- Merit Medical Systems, Inc.
- Sold / distributed
- United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Why it was recalled
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
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