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Terminated

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.

FDA Recall Z-2720-2016 · Posted 2016-09-02

Recalling FirmAdvanced Medical Solutions Ltd.
Recall StatusTerminated
Product CodeFRO
Date Initiated2015-01-15
Date Terminated2016-11-23
Product Quantity29,204 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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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