Class 2 Device Recall Advance Medical

• Date Initiated by Firm: July 07, 2023
• Date Posted: September 09, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2533-2023
• Recall Event ID: 92735
• 510(K)Number: K130581
• Product Classification: Media, coupling, ultrasound - Product Code MUI
• Product: 50-GEL20; Ultrasound gel
• Code Information: Lot Number 21043C2328
• Recalling Firm/ Manufacturer: Advance Medical Designs, Inc.; 1241 Atlanta Industrial Dr; Marietta GA 30066-6606
• For Additional Information Contact: Carrie Farmer; 770-422-3125
• Manufacturer Reason for Recall: Ultrasound gel mislabeled with inappropriate use.
• FDA Determined Cause: Other
• Action: Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.
• Quantity in Commerce: 13750 units
• Distribution: US, Canada, UK, Panama, Netherlands
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MUI and Original Applicant = TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA