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 for a medical device. The rubric classifies minor labeling errors and voluntary precautionary recalls as Moderate (Score 2).
Plain-English summary
ASP Global, LLC. is recalling sterile disposable tourniquet cuffs, model ASP-564006, due to incorrect expiration dates. The affected products were manufactured between September 2016 and March 2023. These devices are intended to be wrapped around a patient's limb and inflated to reduce or occlude circulation during surgery.
The recall was initiated because the products are labeled with a 10-year shelf life, whereas the correct validated shelf life is 5 years. The recall covers 36,680 units distributed nationwide in 34 states, including 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.
Specific lot codes affected include P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0730STY, M1015STY, M1101STY, M1115STY, L0310STY, and L0325STY. Healthcare facilities and consumers should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce…
- Manufacturer
- ASP Global, LLC.
- Hazard
- Affected units
- 36,680
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
- N0730STY
- M0130STY
- M0730STY
- M1015STY
- M1101STY
- M1115STY
- L0310STY
- L0325STY
Distribution
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