FDA-Device2018-02-21Class II
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.
Smiths Medical ASD, Inc.
Hazard
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Sold states
International Distribution to:Germany
Affected count
1
Manufactured in
5700 W 23rd Ave, Gary, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0577-2018Don't want to check this manually?
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