Asp Global, Llc.: Tourniquet, Pneumatic
ASP Global is recalling Expressaire Disposable Tourniquet Cuffs (model A70107007) distributed nationwide because they were labeled with an incorrect 10-year shelf life when the validated shelf life is actually 5 years. The cuffs, which are sterile devices used to restrict blood flow during surgery, were manufactured between September 2016 and March 2023 and may have exceeded their safe usable period. This is a Class I recall, the most serious classification.
- Recalling firm
- ASP Global, LLC.
- Product
- Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 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
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d1d9fc78-8bb4-451c-81f2-f8cda6913f23