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 and involves a labeling error regarding shelf life. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate (Score 2).
Plain-English summary
ASP Global, LLC. is recalling 2,244 units of Expressaire Disposable Tourniquet Cuffs (Model A70107013) due to incorrect expiration dates on the product. The affected devices were manufactured between September 2016 and March 2023. The products are currently labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The recall covers all lots produced during the specified period, including lot codes S0922STY, R0310STY, R0601STY, R0801STY, Q1115STY, P0620STY, O0120STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY, and L0120STY. The devices were distributed nationwide in 34 states, including 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.
These sterile disposable tourniquet cuffs are used in surgical procedures to reduce or occlude circulation in a patient's limb. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare facilities and consumers should stop using the affected products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 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.
- Hazard
- Affected units
- 2,244
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 (12)
- R0310STY
- R0601STY
- R0801STY
- Q1115STY
- P0620STY
- O0120STY
- N0330STY
- N0730STY
- M0130STY
- M0730STY
- M0930STY
- L0120STY
Distribution
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