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, but 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, which typically corresponds to a moderate severity score. The issue is a labeling error regarding shelf life, which is a documentation and labeling defect rather than a direct physical hazard or reported injury.
Plain-English summary
ASP Global, LLC. is recalling sterile disposable tourniquet cuffs, model ASP-564012, due to incorrect expiration dates. The products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The recall affects 53,040 units of the 34" x 4" 1-Line, Blue tourniquet cuffs. These devices are intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. The recall covers all lots produced between September 1, 2016, and March 1, 2023, including specific lot codes such as P1015STY, P1215STY, and O0815STY.
The affected products were distributed nationwide in the United States, including states such as 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. Users should check their inventory for the affected model and lot codes and stop using the products if they fall within the recalled range.
The recalled product
- Product
- Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-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.
- Hazard
- Affected units
- 53,040
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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