Reported Sep 20, 2023 · Ongoing
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, 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) 28-EG103b) 28-EG125c) 28-EG135d) 28-EG151e) 28-EG161f) 28-EG163g) 28-EG197
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 10717C1190 2 28-EG125, Lot Numbers: 30552C3318 3 28-EG135, Lot Numbers: 10634C1175, 220221C2163 4 28-EG151, Lot Numbers: 20655C2250, 20814C2279 5 28-EG161, Lot Numbers: 10759C1198 6 28-EG163, Lot Numbers: 10614C1166 7 28-EG197, Lot Numbers: 10710C1190, 20804C2274 - Amount recalled
- 460 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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