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Advance Medical Designs, Inc. recalls procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 2

Recalled September 20, 2023 · FDA recall Z-2537-2023 · Advance Medical Designs

Hazard
Ultrasound gel mislabeled with inappropriate use. · FDA Class II
Units
1880 units
Sold at
US, Canada, UK, Panama, Netherlands

Description

Ultrasound gel mislabeled with inappropriate use.

Product
procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-GG307, i)¿¿¿¿¿¿ 28-GG519, j)¿¿¿¿¿¿ 28-GG519PC, k)¿¿¿¿¿ 28-GG521, l)¿¿¿¿¿¿ 28-GG521PC, m)¿¿¿ 28-GG529, n)¿¿¿¿ 28-GG553, o)¿¿¿¿ 28-GG569, p)¿¿¿¿ 28-GG571, q)¿¿¿¿ 28-GG723
Manufacturer(s)
Advance Medical Designs, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov