Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Reported: September 20, 2023 Initiated: July 7, 2023 #Z-2535-2023
Product Description
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Reason for Recall
Ultrasound gel mislabeled with inappropriate use.
Details
- Recalling Firm
- Advance Medical Designs, Inc.
- Units Affected
- 117875 units
- Distribution
- US, Canada, UK, Panama, Netherlands
- Location
- Marietta, GA
Frequently Asked Questions
What product was recalled? ▼
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648. Recalled by Advance Medical Designs, Inc.. Units affected: 117875 units.
Why was this product recalled? ▼
Ultrasound gel mislabeled with inappropriate use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2023. Severity: Moderate. Recall number: Z-2535-2023.
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