FDA Enforcement
Class II
Ongoing
50-GEL20; Ultrasound gel
Recall: Z-2533-2023
·
Reported September 20, 2023
Enforcement
- Recall Number
- Z-2533-2023
- Event ID
- 92735
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Advance Medical Designs, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 20, 2023
- Initiation Date
- July 7, 2023
- Classification Date
- September 8, 2023
- Address
- 1241 Atlanta Industrial Dr, Marietta, GA, 30066-6606, United States
Description
50-GEL20; Ultrasound gel
Reason
Ultrasound gel mislabeled with inappropriate use.
Code Info
Lot Number 21043C2328
Distribution
US, Canada, UK, Panama, Netherlands
Quantity
13750 units