Reported Sep 20, 2023 · Ongoing
procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿…
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-GG023b)¿¿¿¿ 28-GG105c)¿¿¿¿¿ 28-GG107d)¿¿¿¿ 28-GG121e)¿¿¿¿ 28-GG219f)¿¿¿¿¿¿ 28-GG223g)¿¿¿¿¿ 28-GG303h)¿¿¿¿ 28-GG307i)¿¿¿¿¿¿ 28-GG519j)¿¿¿¿¿¿ 28-GG519PCk)¿¿¿¿¿ 28-GG521l)¿¿¿¿¿¿ 28-GG521PCm)¿¿¿ 28-GG529n)¿¿¿¿ 28-GG553o)¿¿¿¿ 28-GG569p)¿¿¿¿ 28-GG571q)¿¿¿¿ 28-GG723
- Lot codes and dates
17 of 17 products
Products covered by this recall # Product as published 1 20794C0208 2 ¿¿¿¿ 28-GG105, Lot Numbers: 21123C2346 3 ¿¿¿¿¿ 28-GG107, Lot Numbers: 21039C2325 4 ¿¿¿¿ 28-GG121, Lot Numbers: 21125C2346 5 ¿¿¿¿ 28-GG219, Lot Numbers: 30440C2419 6 ¿¿¿¿¿¿ 28-GG223, Lot Numbers: 21120C2341 7 ¿¿¿¿¿ 28-GG303, Lot Numbers: 10484C1000 8 ¿¿¿¿ 28-GG307, Lot Numbers: 20599C2238 9 ¿¿¿¿¿¿ 28-GG519, Lot Numbers: 20599C2238 10 ¿¿¿¿¿¿ 28-GG519PC, Lot Numbers: 20709C2256 11 ¿¿¿¿¿ 28-GG521, Lot Numbers: 21126C2346 12 ¿¿¿¿¿¿ 28-GG521PC, Lot Numbers: 21128C2346 13 ¿¿¿ 28-GG529, Lot Numbers: 20783C0208 14 ¿¿¿¿ 28-GG553, Lot Numbers: 10486C1000, 20816C2280 15 ¿¿¿¿ 28-GG569, Lot Numbers: 21124C2346 16 ¿¿¿¿ 28-GG571, Lot Numbers: 30502C2449 17 ¿¿¿¿ 28-GG723, Lot Numbers: 30502C2449 - Amount recalled
- 1880 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.
Want the full recall guide?
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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