FDA-Device2026-10-07Class IIMISBRANDING

ASP Global MPR tourniquet cuff recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's MPR Single Use Tourniquet Cuff (model DT-7044-02Q) 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 have incorrect expiration dates printed on the packaging. This could result in use of sterile devices beyond their proven safe timeframe.

  • Check the lot code on your tourniquet cuff packaging against the affected list (S0823STY, R1201STY, N0330STY, N0530STY, M0730STY, M0930STY).
  • Verify the manufacture date fell between September 2016 and March 2023.
  • Do not use affected cuffs beyond the correct 5-year shelf life from manufacture date.
  • Contact ASP Global or your supplier for replacement stock or further guidance.
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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
360
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q 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-0060-2027

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