FDA Recalls MPR Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling MPR Disposable Tourniquet Cuffs because the expiration date is incorrect. The product is 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, but the hazard is a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
ASP Global, LLC. is recalling MPR Disposable Tourniquet Cuffs, Model DB-7020-02Q, due to an incorrect expiration date. The affected products were manufactured between September 2016 and March 2023. The recall is classified as Class II by the FDA.
The products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. The tourniquet cuffs are sterile, non-invasive devices intended for surgical procedures to reduce or occlude circulation. The recall covers all lots produced during the specified period, including lot Q1115STY.
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 consumers should stop using the affected products and contact the recalling firm for instructions.
The recalled product
- Product
- Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q 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
- 20
Distribution
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