ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling sterile 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 labeling error regarding shelf life (FDA Class II) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.
Plain-English summary
ASP Global, LLC. is recalling sterile disposable tourniquet cuffs, model ASP-564010, due to incorrect expiration dates on the product packaging. The affected products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The recall includes 34,550 units of the 30" x 4" 1-Line, White tourniquet cuffs. These 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. The recall covers all lots produced between September 1, 2016, and March 1, 2023.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact ASP Global, LLC. for further instructions or a return. The device is intended for use in surgical procedures to interrupt blood flow and visualize the operative field.
The recalled product
- Product
- Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 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.
- Hazard
- Affected units
- 34,550
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 (14)
- P1215STY
- O1020STY
- N0330STY
- N0530STY
- M0130STY
- M0430STY
- M0730STY
- M0930STY
- M1015STY
- M1101STY
- M1115STY
- L0228STY
- L0310STY
- L0325STY
Distribution
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