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U.S. Department of Health and Human Services

Class 2 Device Recall Iamin Moist Dressing and the Iamin Hydrating Gel

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  Class 2 Device Recall Iamin Moist Dressing and the Iamin Hydrating Gel see related information
Date Initiated by Firm March 26, 2015
Date Posted April 23, 2015
Recall Status1 Terminated 3 on August 18, 2015
Recall Number Z-1516-2015
Recall Event ID 70838
510(K)Number K964468  K953853  
Product Classification Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
Product Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
Code Information Item No. Description GCICK Iamin After-Care Kit GC044-1 Iamin Moist Dressing (1) GCIMD Iamin Moist Dressing Kit (7) GCIHG Iamin Hydrating Gel Kit M40329 Iamin Hydrating Gel 15g 20920. Insert, Iamin Care 6 x 4 20939. Iamin Kit Box (GCICK/GCICK) P-GCI624A Iamin Patient Brochure (25) PK PNI-624A Iamin Detail Brochure (25) PK 
Recalling Firm/
Manufacturer		 PhotoMedex, Inc.
100 Lakeside Dr
Horsham PA 19044-2316
For Additional Information Contact Customer Support
888-966-1010
Manufacturer Reason
for Recall		 The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.
FDA Determined
Cause 2		 Labeling design
Action PhotoMedex sent an Urgent product Recall notification, dated March 2015, to direct consignees requesting they discontinue use, complete the response form, and return affected products.
Quantity in Commerce 200188
Distribution Nationwide and Internationally, including Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MGQ and Original Applicant = PROCYTE CORP.
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