Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Reported: September 20, 2023 Initiated: July 7, 2023 #Z-2536-2023
Product Description
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Reason for Recall
Ultrasound gel mislabeled with inappropriate use.
Details
- Recalling Firm
- Advance Medical Designs, Inc.
- Units Affected
- 460 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) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197. Recalled by Advance Medical Designs, Inc.. Units affected: 460 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-2536-2023.
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