Z-1516-2015Class II

Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a...

Name: Z-1516-2015 Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a...
Creator: PhotoMedex, Inc.
Published: 2015-03-26
License: https://open.fda.gov/license/

PhotoMedex, Inc. / initiated 2015-03-26 / Terminated / root cause: labeling and UDI

FDA source

PhotoMedex, Inc. began a recall of 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... on 2015-03-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1516-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Posted: 2015-04-23
Terminated: 2015-08-18
Recalling firm: PhotoMedex, Inc.
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.
Product code: MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 200188
Distribution: Nationwide and Internationally, including Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1516-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1516-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-23

Product code MGQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)