Thin-Flex Venous Cannula, Model Number:TF292902A
Reported: December 16, 2015 Initiated: November 4, 2015 #Z-0398-2016
Product Description
Thin-Flex Venous Cannula, Model Number:TF292902A
Reason for Recall
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 8,915 units
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.
- Location
- Draper, UT
Frequently Asked Questions
What product was recalled? ▼
Thin-Flex Venous Cannula, Model Number:TF292902A. Recalled by Edwards Lifesciences, LLC. Units affected: 8,915 units.
Why was this product recalled? ▼
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0398-2016.
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