Recall Z-2719-2016 ยท FRO Dressing, Wound, Drug
Advanced Medical Solutions Ltd.
ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
| Date | Sep 2, 2016 (initiated Jan 15, 2015) |
| Status | Terminated |
| Reason | On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse |
| Root cause | Package design/selection |
| Action | Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence. |
| Quantity | 47,569 cartons |
| Distribution | OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090453 | SILVER ALGINATE 11 WOUND DRESSING Advanced Medical Solutions Limited, Feb 26, 2009 |