ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because the expiration dates are incorrect. The products are 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 documentation issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs, Model 553322, 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 recall involves 5,015 units distributed nationwide in the United States. The distribution pattern 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, R0310STY, R0801STY, Q0930STY, P0620STY, O0815STY, and N0930STY.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact ASP Global, LLC. for further instructions. The device is intended for use in surgical procedures to interrupt blood flow and visualize the operative field.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
- Manufacturer
- ASP Global, LLC.
- Affected units
- 5,015
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)
- R0310STY
- R0801STY
- Q0930STY
- P0620STY
- O0815STY
- N0730STY
- M0930STY
Distribution
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