ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling 36 units of Expressaire Disposable BB Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding shelf life, which is a moderate risk.
Plain-English summary
ASP Global, LLC. is recalling 36 units of Expressaire Disposable BB Tourniquet Cuffs, Model A70107016. The recall is due to incorrect expiration dates on products manufactured between September 2016 and March 2023. The products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The affected tourniquet cuffs are sterile, non-invasive devices intended to be wrapped around a patient's limb and inflated to reduce or occlude circulation during surgery. The specific lot code for the affected units is P0325STY, and the UDI-DI is (01) 00885914035603.
The products were distributed nationwide in the United States, including 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, and WY. Healthcare facilities and users should stop using the affected products and contact ASP Global, LLC. for further instructions.
The recalled product
- Product
- Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 1-LINE (CS 12) ORANGE Model/Catalog Number: A70107016 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's…
- Manufacturer
- ASP Global, LLC.
- Hazard
- Affected units
- 36
Distribution
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