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PhotoMedex, Inc. recalls Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound e
Recalled April 29, 2015 · FDA recall Z-1516-2015 · PhotoMedex
Hazard
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 Class II
Units
200188
Sold at
Nationwide and Internationally, including Canada.
Description
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.
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.
Manufacturer(s)
PhotoMedex, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →