FDA-Device2026-10-07Class IIMISBRANDING
ASP Global disposable tourniquet cuff recalled for incorrect expiration dating
What this means
ASP Global 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 cuffs may have expired without the label indicating so, potentially compromising their sterility and performance during surgery.
- Check your inventory for ASP Global disposable tourniquet cuffs (model ASP-564006, 18" × 4", red, 1-Line) manufactured between September 2016 and March 2023.
- Verify the actual manufacture date using the lot code on the package.
- Remove any cuffs that have exceeded 5 years from their manufacture date from active use.
- Contact your ASP Global distributor or the company for guidance on affected inventory.
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
36680
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 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-0039-2027More ASP Global recalls
- FDA-Device2026-10-07ASP Global disposable tourniquet cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07ASP Global MPR tourniquet cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07Expressaire disposable tourniquet cuffs recalled for incorrect expiration dating
- FDA-Device2026-10-07Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 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 opera
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