Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
This recall is currently active, issued September 9, 2023. It was issued by Advance Medical Designs, Inc..
- Company
- Advance Medical Designs, Inc.
- Recall Initiated
- July 7, 2023
- Posted
- September 9, 2023
- Recall Number
- Z-2534-2023
- Quantity
- 26900 units
- Firm Location
- Marietta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Ultrasound gel mislabeled with inappropriate use.
Distribution
US, Canada, UK, Panama, Netherlands
Lot / Code Info
a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279
Root Cause
Other
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.
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