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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
Recalled February 21, 2018 · FDA recall Z-0577-2018 · Smiths Medical ASD
Hazard
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization. · FDA Class II
Units
1
Sold at
International Distribution to:Germany
Description
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Product
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.
Manufacturer(s)
Smiths Medical ASD, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →