ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling 260 units of Expressaire Disposable Tourniquet Cuffs because the products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
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 corresponds to a Moderate severity score. The hazard involves a labeling error regarding shelf life, which is a minor labeling error or low-risk contamination issue without reported injuries.
Plain-English summary
ASP Global, LLC. is recalling 260 units of Expressaire Disposable Tourniquet Cuffs, Model 564019. The recall affects units manufactured between September 2016 and March 2023. The products are sterile, non-invasive devices intended to be wrapped around a patient's limb and inflated to reduce or occlude circulation during surgery.
The recall was initiated due to an incorrect expiration date on the product labeling. The affected units are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. The recall covers all lots produced during the specified manufacturing period, identified by the UDI-DI (01) 00885914044698 and lot code R0310STY.
The products were distributed nationwide in the United States, specifically 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 consumers should stop using the affected tourniquet cuffs and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated…
- Manufacturer
- ASP Global, LLC.
- Hazard
- Affected units
- 260
Distribution
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