Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound e
FDA device recall Z-1516-2015 · posted 2015-04-23 · Terminated
Recall details
- Recalling firm
- PhotoMedex, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MGQ
- Quantity affected
- 200188
- Distribution
- Nationwide and Internationally, including Canada.
- Date initiated
- 2015-03-26
- Date posted
- 2015-04-23
- Date terminated
- 2015-08-18
- Location
- Horsham, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IAMIN WET DRESSING (COPPER-SALINE) (K964468) | Procyte Corp. | 1997-02-03 |
| IAMIN GEL WOUND DRESSING (K953853) | Procyte Corp. | 1996-02-05 |