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U.S. Department of Health and Human Services

Class 2 Device Recall FlexiSeal Fecal Management System Advanced Odor Control Kit

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  Class 2 Device Recall FlexiSeal Fecal Management System Advanced Odor Control Kit see related information
Date Initiated by Firm November 20, 2008
Date Posted December 30, 2008
Recall Status1 Terminated 3 on March 09, 2009
Recall Number Z-0618-2009
Recall Event ID 50225
510(K)Number K032734  
Product Classification Gastrointestinal Tubes and Accessories - Product Code KNT
Product Flexi-Seal Fecal Management System Advanced Odor Control Kit.
Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104
ConvaTec
Skillman, NJ
Made in USA with imported components

"For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool."
Code Information Lot number 08-TM-51
Recalling Firm/
Manufacturer		 ConvaTec
200 Headquarters Park Dr
Skillman NJ 08558
For Additional Information Contact Carl Budsen
908-904-2349
Manufacturer Reason
for Recall		 It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent Product Correction Letters were sent by first class mail on November 18, 2008 to Healthcare Professionals and ConvaTec Reps. The reason for the recall was identified along with possible risk to patient. Healthcare professionals were asked to use sufficient lubricating jelly during the insertion process with special care given to those who have a tendency to bleed or are on anti-coagulant medication. Physician should be notified if rectal bleeding or abdominal symptoms develop. ConvaTec reps were asked to contact all health care professionals to whom product or samples were given and reinforce the importance of proper lubrication and following the directions. A return form is to be completed by ConvaTec reps for each visit indicating the name of the Health Care Provider and that the they personally received notice of the product correction. All remaining sample products are to be returned to Besta, Franklin, WI.
Quantity in Commerce 795
Distribution Worldwide Distribution --- including USA and country of Canada.
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.
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