FDA-Device2026-10-07Class IIMISBRANDING

Expressaire disposable tourniquet cuff recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

Expressaire disposable tourniquet cuffs manufactured between September 2016 and March 2023 were labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. This means some units may have been used past their safe expiration date. No injuries have been reported.

  • Check your inventory for affected lot codes: S0922STY, S1101STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P1215STY, O1020STY, N0730STY, M0730STY, M0930STY, or P0915STY.
  • Verify the manufactured date on affected units; discard any past their 5-year expiration.
  • Contact ASP Global, LLC. if you have questions about your specific units.
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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
2304
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 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-0033-2027

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