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Advance Medical Designs, Inc. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 50-GEL20; Ultrasound gelClass IIJul 7, 2023Ultrasound gel mislabeled with inappropriate use. |
| ASG-001; Ultrasound gelClass IIJul 7, 2023Ultrasound gel mislabeled with inappropriate use. |
| Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04Class IIJul 7, 2023Ultrasound gel mislabeled with inappropriate use. |
| procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 2Class IIJul 7, 2023Ultrasound gel mislabeled with inappropriate use. |
| Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 2Class IIJul 7, 2023Ultrasound gel mislabeled with inappropriate use. |
| Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d)Class IIJul 7, 2023Ultrasound gel mislabeled with inappropriate use. |