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 cuffs (model DT-7018-01Q) manufactured between September 2016 and March 2023 are labeled with a 10-year shelf life, but the correct validated shelf life is only 5 years. This means some cuffs may have been used past their safe expiration date, potentially affecting sterility and performance during surgery.

  • Check the manufacture date on any MPR tourniquet cuffs in your facility (lot codes: S1101STY, Q0301STY, P1015STY, N0330STY, or N0530STY).
  • Remove and do not use any cuffs manufactured before March 2018.
  • Contact your supplier or ASP Global for replacement or guidance on affected inventory.
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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
2750
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q 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-0052-2027

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