Expressaire Disposable Tourniquet Cuff Recalled for Incorrect Expiration Date
ASP Global is recalling Expressaire Disposable Tourniquet Cuffs because the expiration date is incorrect. The product is labeled with a 10-year shelf life, but the validated shelf life is 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. The hazard is a labeling error regarding shelf life, which is a moderate risk as it may lead to the use of expired sterile equipment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs, Model 564003, due to an incorrect expiration date on the product. The recall affects units manufactured between September 2016 and March 2023. The products are currently labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The recall covers 3,020 units distributed nationwide in the United States. The distribution includes 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 specific lot codes affected are S0922STY, S1101STY, Q0930STY, Q1115STY, P1015STY, M0730STY, M0930STY, and M1230STY.
Healthcare facilities and consumers should stop using these tourniquet cuffs and contact ASP Global, LLC. for further instructions. The device is a sterile, non-invasive product used to wrap around a patient's limb and inflate to reduce or occlude circulation during surgery.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated…
- Manufacturer
- ASP Global, LLC.
- Affected units
- 3,020
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 (7)
- S1101STY
- Q0930STY
- Q1115STY
- P1015STY
- M0730STY
- M0930STY
- M1230STY
Distribution
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