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U.S. Department of Health and Human Services

Class 2 Device Recall ReliaMed Alginate/CMC

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  Class 2 Device Recall ReliaMed Alginate/CMC see related information
Date Initiated by Firm January 15, 2015
Date Posted September 02, 2016
Recall Status1 Terminated 3 on November 23, 2016
Recall Number Z-2720-2016
Recall Event ID 75033
Product Classification Dressing, wound, drug - Product Code FRO
Product 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.
Code Information 51593 51772 52013 52001 52074 52668 52752 52756 52810 52851 53233 53234 53467 53655 53727 53685 53769 01129 01332 01569 02390 02584 02429 03696 03813 04095 04137 
Recalling Firm/
Manufacturer		 Advanced Medical Solutions Ltd.
Premier Park 33, Road One
Windford Industrial Estate
Winsford United Kingdom
Manufacturer 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
FDA Determined
Cause 2		 Package design/selection
Action Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.
Quantity in Commerce 29,204 cartons
Distribution OH
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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