ASP Global Recalls 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, which typically corresponds to a moderate severity score. The hazard involves a labeling error regarding shelf life, which is a documentation issue rather than a direct physical defect or contamination.
Plain-English summary
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs, Model 564012, due to incorrect expiration dates on the product packaging. The affected devices are sterile, non-invasive cuffs intended to be wrapped around a patient's limb and inflated to reduce or occlude circulation during surgical procedures.
The recall is necessary because the products are labeled with a 10-year shelf life, whereas the correct validated shelf life is 5 years. This discrepancy affects units manufactured between September 2016 and March 2023. The recall covers 26,810 units distributed nationwide in 34 states, including California, Texas, New York, and Florida.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact ASP Global, LLC. for further instructions. The specific lot codes affected include S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O1020STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, and M1230STY.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 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
- 26,810
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)
- S1101STY
- R0601STY
- R1101STY
- Q0301STY
- Q1115STY
- P0325STY
- P0620STY
- P1015STY
- O1020STY
- N0730STY
- M0130STY
- M0430STY
- M0730STY
- M0930STY
- M1230STY
Distribution
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