Safety Investigation of Suspected Counterfeit Combat Application Tourniquets (C-A-T®): Initial Communication Safety Investigation of Suspected Counterfeit Combat Application Tourniquets (C-A-T®): Initial Communication Date Issued: August 9, 2010 Audience: Individuals who use tourniquets: Military Purchasers, Military Personnel, Emergency First Responders (Fire Fighters, EMTs, Police Officers), Individuals who may find themselves in a situation where they need to stop severe bleeding: Hunters, Hikers, Rock Climbers Consumers: Friends and Family of Military Personnel, Paintball Players, War Re-enactors Medical Specialty: Emergency Medicine, Emergency Responders, Trauma Device: 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 Symbols on One Side of Tourniquet Summary of Problem and Scope: FDA has become aware of suspected counterfeit C-A-T® tourniquets. The suspected counterfeit tourniquets have subtle differences in stitching, printing of the logo and molding of plastic parts. They may be packaged and labeled for a distributor other than the authorized manufacturer or distributors listed above. 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. Recommendations/Actions: 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. FDA Activities: FDA and the Department of Defense continue to investigate this issue and determine the sources of the suspected counterfeit products. We will update this communication as more information becomes available. Reporting Problems to FDA: Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect a problem with tourniquets, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. To help us learn as much as possible about the adverse events associated with tourniquets, please include the following information in your reports, if available: Manufacturer’s Name Device Name (Brand Name) Date Device was Manufactured Distributor’s Name Details of Adverse Event and Medical and/or Surgical Interventions (if required) Contact Information: If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041, or 301-796-7100. This document reflects FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.