Marietta, GA, United States
Advance Medical Designs, Inc. recalls
1 recall recorded since 2018, most recently on 7 July 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 July 2023
- Reason
- Ultrasound gel mislabeled with inappropriate use.
- Distribution
- US, Canada, UK, Panama, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2532-2023, Z-2533-2023, Z-2534-2023, Z-2535-2023, Z-2536-2023, Z-2537-2023
- ASG-001; Ultrasound gel
- 50-GEL20; Ultrasound gel
- Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
- Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
- 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
- procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.