Merit Medical Systems, Inc. recalls Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant C…
- Recall date
- September 20, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1144-2018
- 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 and placed into these dialysis kits.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Get recall alerts
Free email alert whenever Merit Medical Systems, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Merit Medical Systems, Inc.