procedural kits containing ultrasonic transmission gel recall: Labeling Error
procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿…
Why was procedural kits containing ultrasonic transmission gel recalled?
Ultrasound gel mislabeled with inappropriate use.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿…
- Recalling firm
- Advance Medical Designs, Inc.
- Quantity
- 1880 units
- Distribution
- US, Canada, UK, Panama, Netherlands
- Recall date
- September 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)