FDA Recalls MPR Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling 970 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 and involves a labeling error regarding shelf life. The rubric assigns a score of 2 to minor labeling errors and voluntary precautionary recalls.
Plain-English summary
ASP Global, LLC. is recalling 970 units of MPR Single Use Tourniquet Cuff 24" 2 Line (Model DT-7024-02Q). The recall was initiated because 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 affected lots include R1201STY, Q0301STY, Q1115STY, O1020STY, N0330STY, N0530STY, and M0930STY. 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.
The products were distributed nationwide 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. The source text does not specify the actions consumers or healthcare providers should take.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q 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 totally…
- Manufacturer
- ASP Global, LLC.
- Hazard
- Affected units
- 970
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 (6)
- Q0301STY
- Q1115STY
- O1020STY
- N0330STY
- N0530STY
- M0930STY
Distribution
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