Recall Z-0228-2016— Pyng Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Pyng Medical Corporation, initiated 2015-08-31, terminated 2016-07-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Pyng Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-31
- Terminated
- 2016-07-05
- Firm location
- Richmond, N/A, Canada
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.