FDA Medical Device Recalls (openFDA)
Pyng Medical Corporation: 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
- Recall number
- Z-0228-2016
- Recalling firm
- Pyng Medical Corporation
- 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
- Status
- Terminated
- Initiated
- 2015-08-31
- Posted
- not on file
- Terminated
- 2016-07-05
- 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.
- Root cause
- Process control
- 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. .
- Quantity
- 6728
- Distribution
- 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, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAX
- Firm FEI
- 3003437923
- Firm city
- Richmond
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28