Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating
What this means
ASP Global's Expressaire Disposable Tourniquet Cuff (model 564017) was labeled with a 10-year shelf life, but the actual validated shelf life is 5 years. Products manufactured between September 2016 and March 2023 have incorrect expiration dates printed on the package. This could result in use of sterile tourniquets past their validated safe period during surgery.
- Check your inventory for Expressaire tourniquet cuffs (model 564017) manufactured between September 2016 and March 2023.
- Review lot codes S0922STY, R0310STY, Q0301STY, Q1115STY, O0815STY, O1020STY, and N0330STY.
- Do not use cuffs beyond 5 years from the manufacture date, regardless of the printed expiration date.
- Contact ASP Global for guidance on affected inventory.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2027More 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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