FDA Recalls MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
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, which typically corresponds to a moderate severity score. The hazard involves a labeling error regarding shelf life, which is a minor labeling error or low-risk contamination issue rather than a direct structural defect or reported injury.
Plain-English summary
ASP Global, LLC. is recalling MPR Single Use Tourniquet Cuffs, Model DT-7030-01Q, due to incorrect expiration dates. The products were manufactured between September 2016 and March 2023 and are labeled with a 10-year shelf life, whereas the correct validated shelf life is 5 years.
The recall affects 1,100 units 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. The specific lot codes involved are S1101STY, P1015STY, N0330STY, and N0730STY.
These sterile disposable tourniquet cuffs are intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. Users should check their inventory for the affected model and lot codes. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with the recall instructions.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog Number: DT-7030-01Q 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
- 1,100
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 (3)
- P1015STY
- N0330STY
- N0730STY
Distribution
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