Expressaire Disposable Tourniquet Cuffs Recalled for Incorrect Expiration Dates
ASP Global is recalling Expressaire disposable tourniquet cuffs because they are labeled with a 10-year shelf life, but the 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 typically corresponds to a moderate severity score. The hazard is a labeling error regarding shelf life, which is a documentation issue rather than a direct physical defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs, 38" x 4" 1-Line (CS 10), Model 564044. The recall affects all lots produced between September 1, 2016, and March 1, 2023, with the lot code Q0301STY. These sterile devices are used in surgical procedures to reduce or occlude circulation in a patient's limb.
The recall was initiated due to incorrect expiration dates on the product packaging. The products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. This labeling error may result in the use of devices that have exceeded their validated shelf life.
The affected 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 consumers should check their inventory for this specific model and lot code and stop using the affected products.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
- Manufacturer
- ASP Global, LLC.
- Affected units
- 10
Distribution
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