FDAJanuary 15, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
advanced medical solutionsadvancedadvanced medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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