Angiodynamics Inc. (Navilyst Medical Inc.) product recalled over sterility concerns
- Recall date
- January 13, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Angiodynamics Inc. (Navilyst Medical Inc.) recalls NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
- Recall number
- Z-1853-2017
- FDA classification
- Class II
- Brand / firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Sold / distributed
- CA, KY, MD, OR, VA, TX
Why it was recalled
The product has the potential to be non-sterile as it was not packaged in accordance to specification.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
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