FDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling 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, and the hazard is a labeling error regarding shelf life. No injuries or illnesses are reported, and the risk is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Expressaire Disposable Tourniquet Cuffs, Model A70107005, manufactured by ASP Global, LLC. The recall involves 2,112 units distributed nationwide in 34 states. The product is a sterile, non-invasive device used in surgical procedures to interrupt blood flow and provide clear visualization of the operative field.
The recall was initiated 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. This labeling error may result in the use of expired medical devices.
Healthcare facilities and consumers who have these specific tourniquet cuffs should stop using them and contact ASP Global, LLC. for further instructions. The affected lot codes include S0922STY, S1214STY, R0601STY, R0801STY, Q0301STY, Q1115STY, P0620STY, P1015STY, N0730STY, M0130STY, M0730STY, and M0930STY.
The recalled product
- Product
- Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 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
- 2,112
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 (11)
- S1214STY
- R0601STY
- R0801STY
- Q0301STY
- Q1115STY
- P0620STY
- P1015STY
- N0730STY
- M0130STY
- M0730STY
- M0930STY
Distribution
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