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, while 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 and involves a labeling error regarding shelf life, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
ASP Global, LLC. is recalling 45,960 units of sterile disposable tourniquet cuffs, model ASP-564011. The recall is due to incorrect expiration dates on products manufactured between September 2016 and March 2023. The affected products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The affected tourniquet cuffs are intended for use in surgical procedures to reduce or totally occlude circulation. The recall covers units 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 users should stop using the affected tourniquet cuffs and contact ASP Global, LLC. for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 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
- 45,960
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)
- P1215STY
- O0815STY
- O1020STY
- N0330STY
- N0530STY
- M0430STY
- M0730STY
- M1015STY
- M1101STY
- M1115STY
- L0228STY
- L0310STY
- L0325STY
Distribution
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