Edwards Thin-Flex Venous Cannula Recalled for Incorrect Connector Size Labeling
Edwards Lifesciences is recalling Thin-Flex Venous Cannulas because the product guide incorrectly lists the connector size as 3/8 inch instead of the actual 1/2 inch.
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 Moderate because it involves a minor labeling error regarding the connector size, with no reported injuries or illnesses in the source text.
Plain-English summary
Edwards Lifesciences, LLC has initiated a field action for the Thin-Flex Venous Cannula, Model Number TF292902A. The recall involves 8,915 units distributed worldwide, including the United States and various international markets.
The action was taken because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size for the device is 1/2 inch. This discrepancy is a labeling error in the product documentation.
The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of the device, nor does it report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Thin-Flex Venous Cannula, Model Number:TF292902A
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Venous Cannula
- Hazard
- Affected units
- 8,915
Distribution
Distributed nationwide across the United States.
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