Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall ConvaTec

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall ConvaTec see related information
Date Initiated by Firm June 25, 2013
Date Posted August 20, 2013
Recall Status1 Terminated 3 on January 08, 2014
Recall Number Z-1991-2013
Recall Event ID 65879
510(K)Number K032734  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product 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.
Code Information Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 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
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.
-
-