FDA-Device2023-09-20Class II
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Advance Medical Designs, Inc.
Hazard
Ultrasound gel mislabeled with inappropriate use.
Sold states
US, Canada, UK, Panama, Netherlands
Affected count
460 units
Manufactured in
1241 Atlanta Industrial Dr, Marietta, GA, United States
Products
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2536-2023Don't want to check this manually?
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