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U.S. Department of Health and Human Services

Class 3 Device Recall ConvaTec

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 Class 3 Device Recall ConvaTecsee related information
Date Initiated by FirmJune 25, 2013
Date PostedAugust 20, 2013
Recall Status1 Terminated 3 on January 08, 2014
Recall NumberZ-1990-2013
Recall Event ID 65879
510(K)NumberK032734 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductConvaTec 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.
Code Information Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02.  
FEI Number 3011987967
Recalling Firm/
Manufacturer		 Convatec Inc.
200 Headquarters Park Dr
Skillman NJ 08558-2600
For Additional Information Contact
908-904-2675
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionConvaTec issued a notification letters to their customers dated June 25, 2013 via UPS. The letter informed the customer of the issue with the related product and the action to be taken. If the customer has any question regarding the notification they can contact customer service at 1-800-422-8811.
Quantity in Commerce22,896 units
DistributionUS Nationwide Distribution
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 = KNT
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