ASP Global 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 FDA Class II, which typically corresponds to a moderate severity score. The hazard involves a labeling error regarding shelf life, which is a documentation issue rather than a direct physical defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs, Model 553323, due to incorrect expiration dates on the product. The affected units were manufactured between September 2016 and March 2023. These sterile cuffs are used in surgical procedures to reduce or occlude circulation in a patient's limb.
The recall is necessary because the products are labeled with a 10-year shelf life, whereas the correct validated shelf life is 5 years. This labeling error could lead to the use of expired medical devices. The recall covers all lots produced during the specified period, including lot Q1115STY.
The affected products were distributed nationwide in the United States, specifically 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. Healthcare facilities and consumers should check their inventory for these specific model numbers and manufacturing dates. If found, the products should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 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
- 18
Distribution
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