MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
FDA Recall Z-0228-2016 · Posted None
Recalling FirmPyng Medical Corporation
Recall StatusTerminated
Product CodeGAX
Date Initiated2015-08-31
Date Terminated2016-07-05
Product Quantity6728
Reason for Recall
Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each
tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.
Firm Action
PYNG Medical sent Recall Notification letters dated August 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed:
Please immediately cease use of the MATResponder and MATCombat tourniquet lots specified above. Inform all of your teams to cease use of or distribution of these lots.
Please immediately place all MATResponder Tourniquets and MATCombat Tourniquets that you have in inventory into a quarantined location. For further questions please call (604) 303-7964.
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Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US Distribution and to the countries of : Colombia, France, Canada, Italy, Germany, Finland, United Kingdom, Australia, The Netherlands, Japan, Hungary, Indonesia, Israel, Mexico, Poland and Spain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.