Recall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling MPR Single Use 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 and involves a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ASP Global, LLC. is recalling MPR Single Use Tourniquet Cuffs, Model DB-7024-02Q, due to an incorrect expiration date. The products were manufactured between September 2016 and March 2023 and are labeled with a 10-year shelf life, while the correct validated shelf life is 5 years.
The affected products are sterile disposable tourniquet cuffs intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. The recall covers 50 units distributed nationwide in 34 states, including 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 ASP Global, LLC. for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q 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.
- Hazard
- Affected units
- 50
Distribution
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