Z-0065-2027

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q...

Name: Z-0065-2027 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q...
Creator: ASP Global, LLC.
Published: 2026-08-24
License: https://open.fda.gov/license/

ASP Global, LLC. / initiated 2026-08-24 / Open, Classified

FDA source

Recall record

Recall number: Z-0065-2027
Status: Open, Classified
Initiated: 2026-08-24
Posted: 2026-10-01
Recalling firm: ASP Global, LLC.
Product: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
FDA root cause: Under Investigation by firm
Action: On 08/24/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that, ASP Global identified a discrepancy between the labeled shelf life and available shelf-life validation data for certain Sterile Disposable Tourniquet Cuff products. While affected products were labeled with a 10-year shelf life, available validation documentation supports a shelf life of 5-years. Customer are instructed to: a) Review Appendix A to identify affected item codes and lot numbers. b) Discontinue use of the affected products. c) Quarantine any remaining impacted inventory to prevent further use. d) Complete and return the enclosed Recall Response Form to confirm receipt and actions to [email protected]. e) Dispose remaining inventory in accordance with the local facility s guidelines or notify ASP Global at [email protected] for return authorization and disposal assistance. f) If customers have distributed affected products to other facilities or customers, notify those recipients of this recall and provide them with a copy of this notification. For questions regarding this recall, contact: ASP Global Field Actions Team Email: [email protected] Phone: (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM EST
Quantity in commerce: 180
Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.
Product codes and lots: Lot Code: Model Number:DT-7115-02Q UDI-DI: UDI UDI was not applicable at time of manufacture. All Lots produced from 01SEP2016 to 01MAR2023: S1101STY, P1015STY, N0330STY

Product code KCY

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 2026-10-09. View this recall on fda.gov (opens on fda.gov)