Smiths Medical ASD, Inc. recalls Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of C…
- Recall date
- July 15, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0577-2018
- FDA classification
- Class II
- Brand / firm
- Smiths Medical ASD, Inc.
- Sold / distributed
- International Distribution to:Germany
Why it was recalled
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
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 Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
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