Reported Sep 20, 2023 · Ongoing
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
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-PMT03b) 20PMT04
- Lot codes and dates
- a) 20-PMT03
- Lot Numbers30479C3299 b) 20-PMT04
- Lot Numbers30394C3279
- Amount recalled
- 26900 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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