FDA-Device2016-09-14Class II
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.
Advanced Medical Solutions Ltd.
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
Sold states
OH
Affected count
29,204 cartons
Manufactured in
Premier Park 33, Road One, Windford Industrial Estate, Winsford, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2720-2016Don't want to check this manually?
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