Reported Sep 20, 2023 · Ongoing
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d)…
Advance Medical Designs, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advance Medical Designs, Inc. · 1241 Atlanta Industrial Dr · Marietta, GA · 30066-6606
Is this the product you have?
- Procedural kits containing ultrasonic transmission gel
- Item Numbers
a) 20-PC424b) 20-PC448c) 20-PC548d) 20-PC596e) 20-PC648
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 21109C2345 2 20-PC448, Lot Numbers: 30371C3276 3 20-PC548, Lot Numbers: 21088C2341, 30353C3268 4 20-PC596, Lot Numbers: 20622C2244, 30481C3301 5 20-PC648, Lot Numbers: 20145C2088, 20163C2097 - Amount recalled
- 117875 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Ultrasound gel mislabeled with inappropriate use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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