ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling 70 units of Expressaire 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, but the hazard is a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ASP Global, LLC. is recalling 70 units of Expressaire Disposable Tourniquet Cuffs, Model 564005. The recall affects lots produced between September 1, 2016, and March 1, 2023, identified by the lot code P0325STY. The products were distributed nationwide in 34 states.
The recall was initiated because the products are labeled with a 10-year shelf life, whereas the correct validated shelf life is 5 years. This discrepancy means the expiration dates printed on the packaging are incorrect. The tourniquet cuffs are sterile, non-invasive devices used in surgical procedures to interrupt blood flow and provide clear visualization of the operative field.
Healthcare facilities and consumers who possess these specific units should stop using them and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 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.
- Hazard
- Affected units
- 70
Distribution
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