Recall Z-2534-2023 ยท ITX Transducer, Ultrasonic, Diagnostic
Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
| Date | Sep 9, 2023 (initiated Jul 7, 2023) |
| Status | Open, Classified |
| Reason | Ultrasound gel mislabeled with inappropriate use. |
| Root cause | Other |
| Action | 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. |
| Quantity | 26900 units |
| Distribution | US, Canada, UK, Panama, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.