Advanced Medical Solutions Ltd. recalls ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secon…

Recall date

January 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2720-2016

FDA classification

Class II

Brand / firm

Advanced Medical Solutions Ltd.

Sold / distributed

OH

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ReliaMed¿ 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.