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U.S. Department of Health and Human Services

Class 2 Device Recall Advance Medical

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 Class 2 Device Recall Advance Medicalsee related information
Date Initiated by FirmJuly 07, 2023
Date PostedSeptember 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2536-2023
Recall Event ID 92735
Product Classification Guide, needle, surgical - Product Code GDF
ProductProcedural 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
Code Information a) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274;
Recalling Firm/
Manufacturer
Advance Medical Designs, Inc.
1241 Atlanta Industrial Dr
Marietta GA 30066-6606
For Additional Information ContactCarrie Farmer
770-422-3125
Manufacturer Reason
for Recall
Ultrasound gel mislabeled with inappropriate use.
FDA Determined
Cause 2
Other
ActionAdvance 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 Commerce460 units
DistributionUS, Canada, UK, Panama, Netherlands
Total Product Life CycleTPLC 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.
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