FDA Recalls MPR Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling MPR Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life, but the validated shelf life is only 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 source text indicates the issue is a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for MPR Disposable Tourniquet Cuffs (Model DT-7218-02Q) manufactured by ASP Global, LLC. The recall affects 5,440 units of the sterile, non-invasive device, which is used to wrap around a patient's limb and inflate to reduce or occlude circulation during surgery.
The reason for the recall is an incorrect expiration date on the product. The devices are 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 S0922STY, S1101STY, R1201STY, Q1115STY, P1015STY, 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. Healthcare facilities and consumers should stop using the affected products and contact ASP Global, LLC. for further instructions.
The recalled product
- Product
- Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q 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…
- Manufacturer
- ASP Global, LLC.
- Hazard
- Affected units
- 5,440
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 (5)
- S1101STY
- R1201STY
- Q1115STY
- P1015STY
- N0530STY
Distribution
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