Stryker Color Cuff Tourniquet Cuffs Recalled for Incorrect Connector
Stryker is recalling specific Color Cuff tourniquets because they may have the wrong connector, which can make the system inoperable.
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. The hazard is a functional defect (inoperable system) rather than a direct physical injury or contamination, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling Stryker Color Cuff sterile disposable tourniquet cuffs (REF 5921-034-135). The recall involves 5 boxes (50 units) from Lot 50731155, which has a purple color code. These products were distributed in Michigan, Ohio, and Texas.
The recall is being issued because a customer reported receiving a luer connector instead of the intended quick connect fitting. The source text notes that an incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump.
Healthcare facilities and consumers who possess these specific tourniquet cuffs should stop using them and contact Stryker for instructions on how to return or replace the product.
The recalled product
- Product
- Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
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 (1)
- Lot 50731155 Color code Purple
Distribution
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