Reported Apr 29, 2015 · Terminated
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound…
PhotoMedex, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PhotoMedex, Inc. · 100 Lakeside Dr · Horsham, PA · 19044-2316
Is this the product you have?
- Iamin Moist
- Dressing and the Iamin Hydrating Gelintended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination
- Lot codes and dates
- 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
- Amount recalled
- 200188
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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