FDA Recalls MPR 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: This is an FDA Class II recall involving a labeling error (incorrect shelf life) without reported injuries or illnesses, which aligns with the 'Moderate' severity criteria for minor labeling errors or low-risk issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling MPR Single Use Tourniquet Cuffs (Model DT-7112-01Q) manufactured by ASP Global, LLC. The recall involves 30 units of the sterile disposable tourniquet cuffs, which are used in surgical procedures to reduce or occlude blood flow.
The reason for the recall is an incorrect expiration date on the product. The cuffs were labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. The affected lots were produced between September 1, 2016, and March 1, 2023, and include lot codes O1020STY and N0530STY.
The products were distributed nationwide in 34 states, including Missouri, Nevada, Indiana, Minnesota, Georgia, Wisconsin, Pennsylvania, Texas, Connecticut, Louisiana, New Jersey, Florida, Alabama, New York, South Carolina, Nebraska, North Carolina, Ohio, Arizona, Colorado, Massachusetts, Illinois, Kentucky, California, Virginia, Maine, Kansas, Maryland, Tennessee, Mississippi, Arkansas, Washington, New Mexico, Michigan, and Wyoming. Consumers and healthcare facilities should stop using these products and contact the recalling firm for instructions.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q 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.
- Hazard
- Affected units
- 30
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)
- N0530STY
Distribution
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