FDA-Device2026-10-07Class IIMISBRANDING

ASP Global disposable tourniquet cuffs recalled for incorrect expiration dates

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global disposable tourniquet cuffs (model ASP-564003) manufactured between September 2016 and March 2023 were labeled with a 10-year shelf life, but the actual validated shelf life is 5 years. This means some cuffs may have been used beyond their safe sterility window in surgical procedures.

  • Check tourniquet cuffs for lot codes P1015STY through M1115STY and L0228STY through L0325STY (full list in recall details).
  • Do not use cuffs that have exceeded 5 years from their manufacturing date.
  • Contact ASP Global or your supplier for replacement products or instructions.
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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
10060
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 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-0038-2027

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