Home / Recalls / PhotoMedex, Inc. / Z-1516-2015

Z-1516-2015 Class II Terminated

Recalled by PhotoMedex, Inc. — Horsham, PA

Recall Details

Product Type: Devices
Report Date: April 29, 2015
Initiation Date: March 26, 2015
Termination Date: August 18, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 200188

Product 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 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.

Distribution Pattern

Nationwide and Internationally, including Canada.

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