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, but the hazard is a labeling error regarding shelf life without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Expressaire Disposable Tourniquet Cuffs, Model A70107012, manufactured by ASP Global, LLC. The recall involves 2,304 units of the sterile, non-invasive device, which is used in surgical procedures to interrupt blood flow and provide clear visualization of the operative field.
The recall was initiated due to incorrect expiration dates on the product. The devices are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. The affected lots were produced between September 1, 2016, and March 1, 2023. Specific lot codes include S0922STY, S1101STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P1215STY, O1020STY, N0730STY, M0730STY, and M0930STY.
The products were distributed nationwide in the United States, including 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 check their inventory for these specific lot codes and stop using the affected products. ASP Global, LLC. is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 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
- 2,304
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 (10)
- S1101STY
- R0601STY
- R1101STY
- Q0930STY
- Q1115STY
- P1215STY
- O1020STY
- N0730STY
- M0730STY
- M0930STY
Distribution
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