FDA Recalls MPR Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global 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 due to a labeling error regarding shelf life. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for MPR Single Use Tourniquet Cuffs (Model DT-7018-01Q) manufactured by ASP Global, LLC. The recall affects 2,750 units distributed nationwide across 34 states. The product is a sterile, disposable tourniquet cuff intended for surgical procedures to reduce or occlude blood flow.
The recall was initiated due to incorrect expiration dates on products manufactured between September 2016 and March 2023. The affected products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. Specific lot codes affected include S1101STY, Q0301STY, P1015STY, N0330STY, and N0530STY.
Healthcare facilities and consumers should stop using these products and contact ASP Global, LLC. for further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q 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
- 2,750
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 (4)
- Q0301STY
- P1015STY
- N0330STY
- N0530STY
Distribution
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