FDA-Device2026-10-07Class IIMISBRANDING

ASP Global Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's Expressaire Disposable Tourniquet Cuff (model 553323) was labeled with a 10-year shelf life, but the actual validated shelf life is only 5 years. Affected units were manufactured between September 2016 and March 2023. Using an expired tourniquet cuff during surgery could compromise its sterility and performance.

  • Check tourniquet cuff packages for lot code Q1115STY and manufacturing dates between September 2016 and March 2023.
  • Review the actual expiration date versus the labeled date — discard any cuffs past the 5-year mark from manufacture.
  • Contact your ASP Global distributor or the company 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
18
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 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-0004-2027

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