Date Initiated by Firm |
June 25, 2013 |
Date Posted |
August 20, 2013 |
Recall Status1 |
Terminated 3 on January 08, 2014 |
Recall Number |
Z-1990-2013 |
Recall Event ID |
65879 |
510(K)Number |
K032734
|
Product Classification |
Tubes, gastrointestinal (and accessories) - Product Code KNT
|
Product |
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.
|
Code Information |
Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02. |
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 |
Action |
ConvaTec 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 Commerce |
22,896 units |
Distribution |
US Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = KNT and Original Applicant = CONVATEC, A BRISTOL-MYERS SQUIBB CO.
|