FDA-Device2023-09-20Class II
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Advance Medical Designs, Inc.
Hazard
Ultrasound gel mislabeled with inappropriate use.
Sold states
US, Canada, UK, Panama, Netherlands
Affected count
26900 units
Manufactured in
1241 Atlanta Industrial Dr, Marietta, GA, United States
Products
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2534-2023Don't want to check this manually?
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