Z-0618-2009

Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1...

Name: Z-0618-2009 Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1...
Creator: ConvaTec
Published: 2008-11-20
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2008-11-20 / Terminated / root cause: manufacturing process

FDA source

ConvaTec began a recall of 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... on 2008-11-20. The reason FDA records is "It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0618-2009
Status: Terminated
Initiated: 2008-11-20
Posted: 2008-12-30
Terminated: 2009-03-09
Recalling firm: ConvaTec Limited
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."
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot number 08-TM-51

Product code KNT

K032734Class IIConvatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. / cleared 2004-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)