Recall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling MPR Single Use 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 and involves a labeling error regarding shelf life. No illnesses or injuries are reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
ASP Global, LLC. is recalling MPR Single Use Tourniquet Cuffs, model DT-7034-02Q. The recall involves 4,480 units distributed nationwide in 34 states. The product is a sterile disposable tourniquet cuff used in surgical procedures to reduce or occlude circulation.
The recall is due to incorrect expiration dates on products manufactured between September 2016 and March 2023. The products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years. Affected lot codes include S0823STY, S1101STY, R1201STY, Q1115STY, O1020STY, N0330STY, N0530STY, and M0930STY.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact the recalling firm for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally…
- Manufacturer
- ASP Global, LLC.
- Hazard
- Affected units
- 4,480
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 (7)
- S1101STY
- R1201STY
- Q1115STY
- O1020STY
- N0330STY
- N0530STY
- M0930STY
Distribution
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