FDA Recalls MPR Tourniquet Cuffs Due to Incorrect Expiration Date Labeling
ASP Global is recalling MPR Single Use Tourniquet Cuffs because the expiration dates are incorrect. The products 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, but the hazard is a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for MPR Single Use Tourniquet Cuffs manufactured by ASP Global, LLC. The recall affects 410 units of the sterile disposable tourniquet cuffs, model number DT-7044-01Q. These devices are intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
The reason for the recall is an incorrect expiration date on the product. The affected units were manufactured between September 2016 and March 2023. The products are currently labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. The specific lot codes affected are R1201STY and P1015STY.
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 these specific tourniquet cuffs and contact the recalling firm for further instructions.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally…
- Manufacturer
- ASP Global, LLC.
- Affected units
- 410
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- P1015STY
Distribution
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