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.
FDA Recall Z-2719-2016 · Posted 2016-09-02
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Recalling FirmAdvanced Medical Solutions Ltd.
Recall StatusTerminated
Product CodeFRO
Date Initiated2015-01-15
Date Terminated2016-11-23
Product Quantity47,569 cartons
Reason for Recall
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
Firm Action
Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.
Root Cause
Package design/selection
Distribution Pattern
OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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