FDA Recalls 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 Moderate because it involves a labeling error regarding shelf life without reported illnesses or injuries, fitting the criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Expressaire Disposable Tourniquet Cuffs, Model 564007, manufactured by ASP Global, LLC. The recall involves 38,380 units of the sterile, non-invasive device, which is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
The recall is being conducted due to incorrect expiration dates on products manufactured between September 2016 and March 2023. The products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. The affected lots include S0823STY, S0922STY, S1101STY, R0310STY, R0801STY, R1101STY, R1201STY, Q1115STY, P0325STY, P0620STY, N0730STY, M0130STY, M0730STY, M0930STY, and M1230STY.
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 any reported illnesses or injuries associated with this recall.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 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
- 38,380
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 (14)
- S0922STY
- S1101STY
- R0310STY
- R0801STY
- R1101STY
- R1201STY
- Q1115STY
- P0325STY
- P0620STY
- N0730STY
- M0130STY
- M0730STY
- M0930STY
- M1230STY
Distribution
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