Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
FDA device recall Z-2534-2023 · posted 2023-09-09 · Open, Classified
Recall details
- Recalling firm
- Advance Medical Designs, Inc.
- Reason for recall
- Ultrasound gel mislabeled with inappropriate use.
- Action taken
- Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- ITX
- Quantity affected
- 26900 units
- Distribution
- US, Canada, UK, Panama, Netherlands
- Date initiated
- 2023-07-07
- Date posted
- 2023-09-09
- Location
- Marietta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.