Recall Z-1516-2015 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
PhotoMedex, Inc.
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.
| Date | Apr 23, 2015 (initiated Mar 26, 2015) |
| Status | Terminated |
| 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. |
| 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 | 200188 |
| Distribution | Nationwide and Internationally, including Canada. |
| FDA record | Open on fda.gov |