FDA-Device2026-10-07Class IIMISBRANDING
Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration date
What this means
ASP Global's Expressaire Disposable Tourniquet Cuff (Model 564005) was labeled with a 10-year shelf life, but the correct validated shelf life is only 5 years. About 70 units manufactured between September 2016 and March 2023 have incorrect expiration dates printed on them, which could lead to use of expired sterile surgical equipment.
- Check your inventory for Model 564005 tourniquet cuffs manufactured between September 2016 and March 2023 (Lot Code P0325STY).
- Do not use any cuffs that have reached 5 years from their manufacturing date, even if the printed label shows a later date.
- Contact ASP Global or your supplier for instructions on return or replacement.
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
70
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 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-0007-2027More 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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