Z-2532-2023 Class II Ongoing
FDA device recall Z-2532-2023 was initiated by Advance Medical Designs, Inc. on July 7, 2023 and is designated Class II. Reason for recall: Ultrasound gel mislabeled with inappropriate use. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- July 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
ASG-001; Ultrasound gel
Reason for Recall
Ultrasound gel mislabeled with inappropriate use.
Distribution Pattern
US, Canada, UK, Panama, Netherlands
Code Information
Not individually distributed