FDA-Device2023-09-20Class II
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Advance Medical Designs, Inc.
Hazard
Ultrasound gel mislabeled with inappropriate use.
Sold states
US, Canada, UK, Panama, Netherlands
Affected count
117875 units
Manufactured in
1241 Atlanta Industrial Dr, Marietta, GA, United States
Products
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2535-2023Don't want to check this manually?
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