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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.

FDA Recall Z-1516-2015 · Posted 2015-04-23

Recalling FirmPhotoMedex, Inc.
Recall StatusTerminated
Product CodeMGQ
Date Initiated2015-03-26
Date Terminated2015-08-18
Product Quantity200188

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Nationwide and Internationally, including Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964468IAMIN WET DRESSING (COPPER-SALINE)Procyte Corp. · 1997-02-03K953853IAMIN GEL WOUND DRESSINGProcyte Corp. · 1996-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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