Advance Medical Designs, Inc.: 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-

Hazard

Ultrasound gel mislabeled with inappropriate use.

Details from the source

Reason for recall: Ultrasound gel mislabeled with inappropriate use. Distribution: US, Canada, UK, Panama, Netherlands Quantity: 1880 units Lot/code info: a)¿¿¿¿¿ 28-GG023, Lot Numbers: 20794C0208; b)¿¿¿¿ 28-GG105, Lot Numbers: 21123C2346; c)¿¿¿¿¿ 28-GG107, Lot Numbers: 21039C2325; d)¿¿¿¿ 28-GG121, Lot Numbers: 21125C2346; e)¿¿¿¿ 28-GG219, Lot Numbers: 30440C2419; f)¿¿¿¿¿¿ 28-GG223, Lot Numbers: 21120C2341; g)¿¿¿¿¿ 28-GG303, Lot Numbers: 10484C1000; h)¿¿¿¿ 28-GG307, Lot Numbers: 20599C2238; i)¿¿¿¿¿¿ 28-GG519, Lot Numbers: 20599C2238; j)¿¿¿¿¿¿ 28-GG519PC, Lot Numbers: 20709C2256; k)¿¿¿¿¿ 28-GG521, Lot Numbers: 21126C2346; l)¿¿¿¿¿¿ 28-GG521PC, Lot Numbers: 21128C2346; m)¿¿¿ 28-GG529, Lot Numbers: 20783C0208; n)¿¿¿¿ 28-GG553, Lot Numbers: 10486C1000, 20816C2280; o)¿¿¿¿ 28-GG569, Lot Numbers: 21124C2346; p)¿¿¿¿ 28-GG571, Lot Numbers: 30502C2449; q)¿¿¿¿ 28-GG723, Lot Numbers: 30502C2449

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.