FDA-Device2026-10-07Class IIMISBRANDING

ASP Global Expressaire tourniquet cuff recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's 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 5 years. This means some cuffs in use may have exceeded their safe sterility and performance period.

  • Check the lot code on your Expressaire tourniquet cuffs (model A70107016) against the manufacture date.
  • Do not use cuffs manufactured before September 2021 if they are still in your facility.
  • Contact your supplier or ASP Global for guidance on affected inventory.
  • Review your surgical inventory for any cuffs from the affected date range and quarantine them.
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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
36
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 1-LINE (CS 12) ORANGE Model/Catalog Number: A70107016 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-0036-2027

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