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U.S. Department of Health and Human Services

Class 2 Device Recall MATResponder Tourniquet

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 Class 2 Device Recall MATResponder Tourniquetsee related information
Date Initiated by FirmAugust 31, 2015
Create DateNovember 05, 2015
Recall Status1 Terminated 3 on July 05, 2016
Recall NumberZ-0228-2016
Recall Event ID 72096
Product Classification Tourniquet, nonpneumatic - Product Code GAX
ProductMATResponder 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
Code Information MATR: lot numbers; SL115802 (Exp 07/2024), SL12136 (Exp 08/2024), SL121360 (Exp 12/2024), SL114711 (Exp 01/2024) MATC - lot numbers : SL12131 (Exp 07/2024), SL121312 (Exp 08/2024), SL113171 (Exp 10/2023).
Recalling Firm/
Manufacturer		 Pyng Medical Corporation
210-13480 Crestwood Pl
Richmond Canada
For Additional Information ContactParul Cramer
604-303-7964 Ext. 210
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionPYNG 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. .
Quantity in Commerce6728
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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