MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog num...
FDA Device Recall #Z-0228-2016 — Class II — August 31, 2015
Recall Summary
| Recall Number | Z-0228-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 31, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pyng Medical Corporation |
| Location | Richmond, N/A |
| Product Type | Devices |
| Quantity | 6728 |
Product Description
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
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.
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.
Lot / 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).
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.