ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling 6,510 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: 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 6,510 units of sterile disposable tourniquet cuffs, model ASP-564015. The recall affects products manufactured between September 2016 and March 2023. The specific lot codes involved are P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, and L0325STY.
The recall was initiated because the products are labeled with a 10-year shelf life, whereas the correct validated shelf life is 5 years. This discrepancy could lead to the use of the device beyond its intended expiration date.
The affected tourniquet cuffs 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 stop using the affected products and contact ASP Global, LLC. for further instructions or a refund.
The recalled product
- Product
- Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-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
- 6,510
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)
- P1215STY
- O0815STY
- O1020STY
- N0330STY
- N0530STY
- N0730STY
- M0130STY
- M0430STY
- M0730STY
- M0930STY
- M1015STY
- M1101STY
- M1115STY
- L0310STY
- L0325STY
Distribution
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