ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling 6,100 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 and involves a labeling error regarding shelf life. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
ASP Global, LLC. is recalling 6,100 units of Expressaire Disposable Tourniquet Cuffs, Model 564010. The recall affects products manufactured between September 2016 and March 2023. The specific lot codes involved are S0823STY, S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, and M0730STY.
The recall is being conducted 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 devices are sterile, non-invasive tourniquet cuffs intended for surgical procedures to interrupt blood flow and visualize the operative field.
The affected units 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 distributors should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 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
- 6,100
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)
- S0922STY
- S1101STY
- R0601STY
- R1101STY
- Q0301STY
- Q0930STY
- Q1115STY
- P0325STY
- P0620STY
- P1015STY
- M0730STY
Distribution
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