Recall Z-2535-2023— Advance Medical Designs, Inc.

Name: FDA recall Z-2535-2023
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) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648. 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) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648

Reason for recall

Ultrasound gel mislabeled with inappropriate use.

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