Procedural kits containing ultrasonic transmission gel recalled over labeling errors
- Recall date
- July 7, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Advance Medical Designs, Inc. recalls Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC59…
- Recall number
- Z-2535-2023
- FDA classification
- Class II
- Brand / firm
- Advance Medical Designs, Inc.
- Sold / distributed
- US, Canada, UK, Panama, Netherlands
Why it was recalled
Ultrasound gel mislabeled with inappropriate use.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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