Events

Recall of Device Recall Iamin Moist Dressing and the Iamin Hydrating Gel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PhotoMedex, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70838
  • Event Risk Class
    Class 2
  • Event Number
    Z-1516-2015
  • Event Initiated Date
    2015-03-26
  • Event Date Posted
    2015-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135054
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
  • 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.

Device

Device Recall Iamin Moist Dressing and the Iamin Hydrating Gel
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide and Internationally, including Canada.
  • 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.
  • Manufacturer
    PhotoMedex, Inc.

Manufacturer

PhotoMedex, Inc.
  • Manufacturer Address
    PhotoMedex, Inc., 100 Lakeside Dr, Horsham PA 19044-2316
  • Manufacturer Parent Company (2017)
    PhotoMedex Inc.
  • Source
    USFDA