ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit - Not Cleared for Marketing
Recall Class: Class I
Date Recall Initiated: April 29, 2014
Product: The Flexi-Seal CONTROL Fecal Management System (FMS) Kit contains the following components:
- Soft catheter tube assembly
- Luer-Lock Syringe
- Flexi-Seal Privacy collection bag with APS filter
- Cinch clamp
Model Number: ICC 411107
SAP codes: 1704335 for U.S. Products
ConvaTec launched the Flex-Seal CONTROL Fecal Management System Kit in February 2013 as an extension of their Flexi-Seal product family.
All lots of Flexi-Seal CONTROL Fecal Management System Kits are affected by this recall.
The affected device was manufactured from January 2013 through April 2014 and distributed from February 13, 2013 through April 14, 2014. However, the firm did not seek FDA clearance to legally market this device through the 510(k) process.
Use: This device is used in health care facilities to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician. The kit contains a soft catheter that is inserted into the rectum for fecal management. It contains and diverts fecal waste in order to protect the patient's skin and keep the bedding clean. There is a low-pressure retention balloon at the far end and a connector for attaching the collection bag at the other end.
211 American Ave
Greensboro, NC 27409
9900 S 57th Street
Franklin, WI 53132
Fortune Medical Instrument Corporation
6 F. No.29, Sec. 2, Jungjeng E. Road
New Taipei City, Taiwan China 251
Reason for Recall:
The firm received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period February 2013 through March 2014.
A 510(k) application should have been submitted. The Auto-Valve feature that is unique to the Flexi-Seal CONTROL Fecal Management System Kit has not consistently performed relative to the inflation and deflation of the device’s retention balloon. This feature is one of the reasons a 510(k) application should have been submitted.
The following are the failure modes of the device:
- Auto-valve fails to limit inflation to 45mL
- Balloon is unable to be inflated fully
- Balloon is unable to be deflated fully
- Auto-valve leaks at Inflation Port
These failure modes may result in the following health hazards:
- Rectal damage (necrosis/ perforation/ulceration or bleeding)
- Expulsion of the device and/or leakage
- Fecal soiling of bed linen/incontinence pads leading to skin deterioration around the anus, peeling skin, and raw, irritated lesions due to skin contact with fecal matter
In addition to the above adverse health consequences, death may also occur.
Public Contact: For questions about this recall, contact ConvaTec at 1-800-582-6514.
FDA District: New Jersey District Office
More Information about this Recall:
On April 29, 2014, ConvaTec Inc. sent an Urgent Voluntary Medical Device Recall letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
- Stop distributing/using the recalled device.
- Inventory and quarantine the devices in your possession.
- Return the recalled as follows:
- Distributors – to ConvaTec
- Retailers – to ConvaTec
- End-Users – to your distributor
- Contact ConvaTec at 1-800-582-6514 for instructions about the return process
- Even if you currently don’t have the recalled device in your inventory, complete and return the Recall Response Form to ConvaTec.
- If you distributed this device to other customers, forward the Recall letter and Recall Response Form to them and ask that they follow the instructions.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.