ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling 4,530 units of Expressaire Disposable Tourniquet Cuffs because the products are labeled with a 10-year shelf life, but 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, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding shelf life, and the source text does not report any illnesses or injuries.
Plain-English summary
ASP Global, LLC. is recalling 4,530 units of Expressaire Disposable Tourniquet Cuffs, Model 564015. The recall affects lots produced between September 1, 2016, and March 1, 2023. The specific lot codes involved are S0823STY, S0922STY, S1101STY, R1101STY, Q0301STY, Q1115STY, P0620STY, O0815STY, O1020STY, N0730STY, M0130STY, M0730STY, M0930STY, and M1230STY.
The recall was initiated because the products are labeled with a 10-year shelf life, whereas the correct validated shelf life is 5 years. The sterile disposable tourniquet cuffs are intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
The affected 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 check their inventory for the affected model and lot codes and stop using the products if they are past the 5-year validated shelf life.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 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.
- Affected units
- 4,530
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 (13)
- S0922STY
- S1101STY
- R1101STY
- Q0301STY
- Q1115STY
- P0620STY
- O0815STY
- O1020STY
- N0730STY
- M0130STY
- M0730STY
- M0930STY
- M1230STY
Distribution
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