ASP Global Recalls Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling 850 sterile disposable 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, and the hazard is a labeling error regarding shelf life. No illnesses or injuries are reported, fitting the criteria for a moderate severity score.
Plain-English summary
ASP Global, LLC. is recalling 850 units of the MPR Single Use Tourniquet Cuff 34" 1 Line (10), model number DT-7034-01Q. The recall is 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.
The affected lots are R1201STY, Q1115STY, and P1015STY. These sterile disposable tourniquet cuffs are non-invasive devices used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. 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 the affected tourniquet cuffs and contact ASP Global, LLC. for further instructions or a return.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q 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
- 850
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 (2)
- Q1115STY
- P1015STY
Distribution
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