FDA Medical Device Recalls (openFDA)
ConvaTec: 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."
- Recall number
- Z-0618-2009
- Recalling firm
- ConvaTec
- 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."
- Status
- Terminated
- Initiated
- 2008-11-20
- Posted
- 2008-12-30
- Terminated
- 2009-03-09
- Reason
- 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
- 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
- 795
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Lot, serial or model codes
- Lot number 08-TM-51
- 510(k) numbers
- ["K032734"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3011987967
- Firm city
- Skillman
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28