FDA Classifies ConvaTec’s Voluntary Global Recall of Flexi-Seal™ CONTROL Fecal Management System (FMS) as Class I
ConvaTec has announced that the U.S. Food and Drug Administration (FDA)
has classified the company’s recently initiated voluntary global
recall of Flexi-Seal™ CONTROL Fecal Management System (FMS) as a
Class I recall.
The FDA defines a Class I recall as a situation in which there is a reasonable
probability that use of, or exposure to, a violative product will cause
serious adverse health consequences or death.
ConvaTec began notifying customers in late April that all lots of Flexi-Seal
CONTROL FMS (Model Number: ICC 411107, SAP codes: 1704335 for U.S. Products)
were being urgently recalled. The notification requested that all lots
be quarantined immediately and returned to the company as soon as possible.
ConvaTec also notified regulatory agencies in all countries where product
was distributed.
Flexi-Seal CONTROL FMS is a temporary containment device used for the
management of acute fecal incontinence in patients who are often immobilized
and critically ill and have little or no bowel control and liquid or semi-liquid stool.
In the U.S., the decision to voluntarily recall was made following the
determination that Flexi-Seal CONTROL FMS should have a 510(k) clearance,
rather than the use of the current Note to File that was based on existing
510(k) clearance for other Flexi-Seal products.
The company 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 causal link has not been established
for all reported events.
The company also conducted an analysis following reports that the Auto-Valve
feature that is unique to Flexi-Seal CONTROL FMS had not been consistently
performing relative to the inflation and deflation of the device’s
retention balloon.
Inconsistent performance of the Auto-Valve feature may result in the following
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.
For these reasons and to address any potential risk of harm, ConvaTec
voluntarily initiated a global recall of all Flexi-Seal CONTROL FMS kits.
The recall does not affect any of the other Flexi-Seal products or Flexi-Seal
Privacy Collection Bags, which are sold separately.
Customers with questions regarding the recall should contact the ConvaTec
customer service center at 1-800-422-8811 (Monday-Friday, 8:30am –
7:00pm EST).
Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA's MedWatch Adverse Event Reporting
program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
About ConvaTec
ConvaTec is a global medical products and technologies company, with leading
market positions in ostomy care, wound therapeutics, continence and critical
care, and infusion devices. Our products provide a range of clinical and
economic benefits, including infection prevention, protection of at-risk
skin, improved patient outcomes and reduced total cost of care. ConvaTec
has over 8,000 employees, with 11 manufacturing sites in 8 countries,
and we do business in more than 100 countries. We are owned by Nordic
Capital and Avista Capital Partners. More information is available at
www.convatec.com
.