FDA-Device2026-10-07Class IIMISBRANDING

Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's Expressaire Disposable Tourniquet Cuffs (Model 564006) were labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. Cuffs manufactured between September 2016 and March 2023 may have been used past their actual safe expiration date. These sterile cuffs are used during surgery to control blood flow to a patient's limb.

Check the lot code on your Expressaire tourniquet cuffs against the list provided by the FDA.
Do not use cuffs from affected lots that are past 5 years from their manufacture date.
Contact ASP Global or your supplier for instructions on returning or replacing affected cuffs.
Review your facility's inventory of this product and remove affected lots from circulation.

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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

25350

Manufactured in

7800 Third Flag Pkwy, Austell, GA, United States

Products

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 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-0008-2027

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