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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65879
Product Type Devices
Status Ongoing
Recalling Firm Convatec Inc.
City Skillman
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02. Class III ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging. 22,896 units Z-1990-2013
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02. Class III ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging. 22,896 units Z-1991-2013
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