FDA-Device2026-10-07Class IIMISBRANDING

Expressaire tourniquet cuffs recalled for incorrect shelf life labeling

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's Expressaire disposable tourniquet cuffs were labeled with a 10-year shelf life, but the actual validated shelf life is 5 years. Products manufactured between September 2016 and March 2023 may have incorrect expiration dates printed on the package.

  • Check the manufacture date on your Expressaire tourniquet cuff (Model A70107014).
  • If manufactured between September 2016 and March 2023, verify the labeled expiration date is no more than 5 years from manufacture.
  • Do not use cuffs past their actual 5-year shelf life, even if the label says otherwise.
  • Contact ASP Global or your distributor for instructions on replacement or return.
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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
1056
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A70107014 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-0035-2027

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