Asp Global, Llc.: Tourniquet, Pneumatic
ASP Global is recalling Expressaire brand disposable tourniquet cuffs (model 564006) distributed nationwide because they were labeled with an incorrect 10-year shelf life when the validated shelf life is actually 5 years. The affected cuffs were manufactured between September 2016 and March 2023. These sterile cuffs are used in surgical procedures to restrict blood flow to a patient's limb during operations.
- Recalling firm
- ASP Global, LLC.
- Product
- 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
- 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/ee04f50a-ade7-4960-8962-87281d6bb03d