FDA Recall
Terminated
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.
Recall: Z-1516-2015
·
Initiated March 26, 2015
Recall
- Recall Number
- Z-1516-2015
- Event Number
- 70838
- Firm
- PhotoMedex, Inc.
- FEI Number
- 3000206133
- Product Code
- MGQ
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- March 26, 2015
- Posted
- April 23, 2015
- Terminated
- August 18, 2015
- Address
- 100 Lakeside Dr, Horsham, PA, 19044-2316
Description
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.
Reason
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.
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.
Distribution
Nationwide and Internationally, including Canada.
Quantity
200188