Ultrasound gel procedural kits recalled for mislabeled use instructions
Advance Medical Designs is recalling 1880 ultrasound gel procedural kits due to mislabeling that indicates inappropriate use. The affected kits were distributed in the US, Canada, UK, Panama, and the Netherlands.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a labeling defect that creates risk of improper use. No illnesses or injuries are reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Advance Medical Designs, Inc. is recalling 1880 ultrasound gel procedural kits across multiple item numbers (28-GG023 through 28-GG723). The kits contain ultrasonic transmission gel for use in medical procedures.
The recall was initiated because the gel is mislabeled with instructions indicating inappropriate uses. This labeling error could result in improper use of the product in clinical settings.
The affected kits were distributed to healthcare facilities and medical professionals in the United States, Canada, the United Kingdom, Panama, and the Netherlands. Specific lot numbers are provided in the FDA recall notice.
If you have one of the affected kits, discontinue use and contact Advance Medical Designs, Inc. or consult the FDA recall notice for instructions regarding return or replacement.
The recalled product
- 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)¿¿¿¿¿
- Manufacturer
- Advance Medical Designs, Inc.
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- j)¿¿¿¿¿¿ 28-GG519PC
- Lot Numbers: 20709C2256
- k)¿¿¿¿¿ 28-GG521
Distribution
Distribution scope not specified by the agency.
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