Recall Z-2532-2023— Advance Medical Designs, Inc.

Name: FDA recall Z-2532-2023
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. It names one FDA 510(k) clearance: K130581. Product: ASG-001; Ultrasound gel. 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

510(k) clearances named in this recall

1 on FDA's record

K130581 — KONIX STERILE GELTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa·cleared 2014-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ASG-001; Ultrasound gel

Reason for recall

Ultrasound gel mislabeled with inappropriate use.

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