FDA Recalls Expressaire 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. This aligns with the rubric criterion for 'Minor labeling errors' or 'voluntary precautionary recalls' where no specific injuries or illnesses are reported in the source text.
Plain-English summary
ASP Global, LLC. is recalling 7,650 units of Expressaire Disposable Tourniquet Cuffs, Model 564009. These sterile, non-invasive medical devices are used in surgical procedures to wrap around a patient's limb and reduce or occlude circulation to provide clear visualization of the operative field.
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 lots include S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, and M1230STY.
The 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 stop using the affected tourniquet cuffs and contact the recalling firm for further instructions.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 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.
- Affected units
- 7,650
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 (16)
- S1101STY
- R0801STY
- R1101STY
- Q0301STY
- Q1115STY
- P0325STY
- P0620STY
- P1015STY
- O0815STY
- N0330STY
- N0730STY
- M0130STY
- M0430STY
- M0730STY
- M0930STY
- M1230STY
Distribution
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