Device product

50-GEL20; Ultrasound gel

Z-2533-2023

July 07, 2023

Class II

Product summary

Firm: Advance Medical Designs, Inc.
Event: Event 92735
Status: Ongoing
Classification: Class II
Quantity: 13750 units
Official record key: device-enforcement:Z-2533-2023

Official wording

Reason: Ultrasound gel mislabeled with inappropriate use.

Code information: Lot Number 21043C2328

Distribution pattern: US, Canada, UK, Panama, Netherlands

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

mislabeled