ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling 1,692 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, but the hazard is a minor labeling error regarding shelf life with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
ASP Global, LLC. is recalling 1,692 units of Expressaire Disposable Tourniquet Cuffs, Model A70107002. The recall affects sterile tourniquet cuffs used in surgical procedures to interrupt blood flow and visualize the operative field. The products 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.
The recall was initiated because the products, manufactured between September 2016 and March 2023, are labeled with a 10-year shelf life. The correct validated shelf life for these devices is 5 years. The affected lot codes are S0922STY, S1101STY, R0601STY, R0801STY, Q0301STY, P1015STY, O0120STY, N0730STY, and M0130STY.
Healthcare facilities and consumers should stop using these specific tourniquet cuffs and contact ASP Global, LLC. for further instructions or a return. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 1-LINE (CS 12) PLUM Model/Catalog Number: A70107002 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and…
- Manufacturer
- ASP Global, LLC.
- Hazard
- Affected units
- 1,692
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 (8)
- S1101STY
- R0601STY
- R0801STY
- Q0301STY
- P1015STY
- O0120STY
- N0730STY
- M0130STY
Distribution
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