jerrymrc
09-07-2010, 08:01
01. Excerpt From Fda Medwatch.
Safety Investigation Of Suspected Counterfeit Combat Application Tourniquets
(c-a-t®): Initial Communication
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 Nsn 6515-01-521-7976. 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 (see Image On Usamma's Website)
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.
Safety Investigation Of Suspected Counterfeit Combat Application Tourniquets
(c-a-t®): Initial Communication
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 Nsn 6515-01-521-7976. 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 (see Image On Usamma's Website)
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.