FDA-Device2026-10-07Class IIMISBRANDING

ASP Global MPR Disposable Tourniquet Cuff recalled for incorrect expiration date labeling

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's MPR Disposable Tourniquet Cuff (model DB-7020-02Q) was labeled with a 10-year shelf life, but the actual validated shelf life is only 5 years. Products manufactured between September 2016 and March 2023 may have incorrect expiration dates printed on the packaging. Using a cuff past its validated shelf life could compromise its sterility or performance during surgery.

  • Check your inventory for model DB-7020-02Q with lot code Q1115STY manufactured between September 2016 and March 2023.
  • Verify the expiration date on affected cuffs and discard any that are beyond 5 years from the manufacture date.
  • Contact your ASP Global distributor or the FDA if you have questions about affected products.
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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
20
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0050-2027

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