Recall Z-2536-2023— Advance Medical Designs, Inc.

Name: FDA recall Z-2536-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-07

Class II · Ongoing

Class II FDA medical device recall by Advance Medical Designs, Inc., initiated 2023-07-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197. Reason: Ultrasound gel mislabeled with inappropriate use..

Recalling firm: Advance Medical Designs, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-07
Firm location: Marietta, GA, United States

Product description

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197

Reason for recall

Ultrasound gel mislabeled with inappropriate use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.