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: This is a Class II recall involving a labeling error regarding shelf life. The rubric classifies minor labeling errors and voluntary precautionary recalls as Moderate severity.
Plain-English summary
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs, Model 564008, due to incorrect expiration dates on the product. The recall affects units manufactured between September 2016 and March 2023. The products are currently labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The recall involves 4,610 units distributed nationwide in 34 states, including Missouri, Nevada, Indiana, Minnesota, Georgia, Wisconsin, Pennsylvania, Texas, Connecticut, Louisiana, New Jersey, Florida, Alabama, New York, South Carolina, Nebraska, North Carolina, Ohio, Arizona, Colorado, Massachusetts, Illinois, Kentucky, California, Virginia, Maine, Kansas, Maryland, Tennessee, Mississippi, Arkansas, Washington, New Mexico, Michigan, and Wyoming. Specific lot codes affected include S0823STY, S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, N0330STY, N0730STY, M0730STY, and M0930STY.
These 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 FDA has classified this as a Class II recall. Healthcare providers and facilities should check their inventory for the affected model and lot codes and stop using these products if they are past the 5-year validated shelf life.
The recalled product
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 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
- 4,610
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 (17)
- S0922STY
- S1101STY
- S1214STY
- R0310STY
- R0601STY
- R0801STY
- R1101STY
- Q0301STY
- Q0930STY
- Q1115STY
- P0325STY
- P0620STY
- P1015STY
- N0330STY
- N0730STY
- M0730STY
- M0930STY
Distribution
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