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 cuffs (model A70107011) manufactured between September 2016 and March 2023 are labeled with a 10-year shelf life, but the actual validated shelf life is 5 years. This means some cuffs in storage may have exceeded their true expiration date without users knowing.

  • Check the lot code on your Expressaire tourniquet cuffs against the list provided (S0823STY through M1230STY).
  • Do not use cuffs beyond 5 years from the manufacture date, even if the package says 10 years.
  • Contact ASP Global or your supplier for 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
6319
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 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-0032-2027

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