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 are labeled with a 10-year shelf life, but the actual validated shelf life is only 5 years. This means some units in circulation may have passed their true expiration date without being identified as expired.

  • Check your inventory for Expressaire tourniquet cuffs (model A70107008) manufactured between September 2016 and March 2023.
  • Remove and do not use any cuffs with lot codes S0823STY, S1101STY, R0310STY, R0601STY, R1101STY, R1201STY, Q1115STY, P0325STY, P1015STY, N0730STY, M1230STY, or L0120STY.
  • Contact your supplier or ASP Global for instructions on product return or replacement.
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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
12114
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 18) YELLOW Model/Catalog Number: A70107008 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-0029-2027

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