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U.S. Department of Health and Human Services

Class 2 Device Recall ReliaMed Silver Alginate/CMC

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 Class 2 Device Recall ReliaMed Silver Alginate/CMCsee related information
Date Initiated by FirmJanuary 15, 2015
Date PostedSeptember 02, 2016
Recall Status1 Terminated 3 on November 23, 2016
Recall NumberZ-2719-2016
Recall Event ID 75033
510(K)NumberK090453 
Product Classification Dressing, wound, drug - Product Code FRO
ProductReliaMed 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.
Code Information AMS Lot number 51594 51800 51883 51928 52023 52024 52002 52065 52230 52750 52754 52782 52775 52811 53213 53488 53532 53628 53665 53633 53981 53989 54066 01334 01263 01341 02112 02438 02583 02592 02582 02523 03138 03667 03675 03819 03908 03779 04254 04142 05996 06086 06256 
FEI Number 3003080333
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
ActionAdvanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.
Quantity in Commerce47,569 cartons
DistributionOH
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FRO
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