ASP Global Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life, while the correct validated shelf life is 5 years.
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, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
ASP Global, LLC. is recalling the Expressaire Disposable Tourniquet Cuff, 34" X 4" 2-Line (CS 10) Blue, Model/Catalog Number 564013. The recall affects 32,390 units of the sterile device, which is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
The recall was initiated due to an incorrect expiration date 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, R0801STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P0620STY, O0815STY, N0330STY, M0130STY, M0430STY, 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. Users should stop using the affected tourniquet cuffs and contact ASP Global, LLC. for further instructions.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 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
- 32,390
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 (15)
- S0922STY
- S1101STY
- R0801STY
- R1101STY
- Q0301STY
- Q0930STY
- P0325STY
- P0620STY
- O0815STY
- N0330STY
- M0130STY
- M0430STY
- M0730STY
- M0930STY
- M1230STY
Distribution
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