Z-0228-2016Class II

MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC...

Name: Z-0228-2016 MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC...
Creator: Pyng Medical Corporation
Published: 2015-08-31
License: https://open.fda.gov/license/

Pyng Medical Corp. / initiated 2015-08-31 / Terminated / root cause: manufacturing process

FDA source

Pyng Medical Corporation began a recall of MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and... on 2015-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0228-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Posted: 2015-11-05
Terminated: 2016-07-05
Recalling firm: Pyng Medical Corp.
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
Product code: GAX Tourniquet, Nonpneumatic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0228-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0228-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

Product code GAX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)