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Monday, October 03, 2011 1:26 PM
Combat Application Tourniquets (C-A-T): Suspected
Counterfeit Product
"This is a counterfeit product warning from the
FDA:"
By: EMS GENERAL ANNOUNCEMENTS http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221752.htm Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product AUDIENCE: Emergency Medicine, Consumers ISSUE: FDA has become aware of suspected counterfeit C-A-T® tourniquets which have subtle differences in stitching, printing of the logo and molding of plastic parts. Preliminary testing has shown that the suspected counterfeit tourniquet does not perform the same as the tourniquet manufactured by Composite Resources. The windlass is weaker in the suspected counterfeit product and breaks or bends before necessary force can be applied to stop blood flow. Excessive blood loss can endanger the victim’s life and ultimately lead to death. BACKGROUND: The Combat Application Tourniquet (C-A-T®) consists of a strap that is placed around an injured limb (extremity) and then tightened with a tension rod (windlass) until blood flow stops. The windlass is secured in place so that the victim can be transported for emergency care. The tourniquet can be self-applied by the victim or it can be applied by another person. One side of the tourniquet has, among other symbols, a C-A-T® logo with the outline of a cat and the National Supply Number NSN6515-01-521-7976. It is manufactured by Composite Resources and distributed by the following authorized distributors: · North American Rescue, LLC - Greer, SC · Cardinal Health - Mcgaw Park, IL · Owens and Minor - Mechanicsville, VA · American Purchasing Services - Opa Locka, FL · Phoenix Textile Corporation - O’Fallon, MO RECOMMENDATION: · Use only C-A-T® tourniquets manufactured by Composite Resources and purchased from one of the authorized distributors listed above. Others may be counterfeit and may fail in use. · If you have C-A-T® tourniquets you suspect may be counterfeit, replace them as soon as possible with the genuine devices. If a counterfeit fails, it can endanger a patient’s life. · Notify FDA’s Office of Criminal Investigations (OCI) if you suspect your tourniquet is counterfeit by contacting: Alex Alvarado, Special Agent, FDA Office of Criminal Investigations - (240) 276-9407. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm Download form 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 |
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