FDA-Device2026-10-07Class IIMISBRANDING

ASP Global MPR Single Use Tourniquet Cuff recalled for incorrect expiration date labeling

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's MPR Single Use Tourniquet Cuff (model DT-7112-01Q) was labeled with a 10-year shelf life, but the actual validated shelf life is 5 years. Products manufactured between September 2016 and March 2023 may have incorrect expiration dates printed on the packaging. Approximately 30 units were distributed across the United States.

  • Check the manufacture date on your MPR tourniquet cuff packaging against the product lot numbers (O1020STY or N0530STY).
  • Do not use any cuff that has exceeded 5 years from its manufacture date, regardless of the printed expiration date.
  • Contact your supplier or ASP Global for instructions on replacement or return of affected units.
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
30
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0062-2027

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