FDA-Device2026-10-07Class IIMISBRANDING

Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's Expressaire Disposable Tourniquet Cuff (model 564008) was labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. Products manufactured between September 2016 and March 2023 may have incorrect expiration dates printed on the package. This affects approximately 4,610 units distributed nationwide.

  • Check the lot code on your tourniquet cuff packaging against the affected list (S0823STY through M0930STY).
  • Verify the actual manufacturing date; if manufactured September 2016 to March 2023, the product may be expired or near expiration despite the printed date.
  • Do not use expired cuffs in surgical procedures.
  • Contact ASP Global or your supplier for replacement stock.
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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
4610
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 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-0010-2027

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