FDA recall Z-2535-2023

Advance Medical Designs, Inc. · Class II · device

Product

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648

Reason for recall

Ultrasound gel mislabeled with inappropriate use.

Distribution

US, Canada, UK, Panama, Netherlands

Key facts

Status
Ongoing
Initiation date
2023-07-07
Report date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2535-2023