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 | K953853 K964468 |
Product Classification |
Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MGQ
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