Reported Dec 16, 2015 · Terminated
Thin-Flex Venous Cannula, Model Number:TF292902A
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 12050 Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Thin-Flex Venous Cannula
- Model NumberTF292902A
- Lot codes and dates
- Lot No
593840615967793659985533594309415972369559999044594566035974645460010418594982285977923960106398595454645984686460113045595804335988362260121142596080305993129060172116596495805996319660181079
- Lot No
- Amount recalled
- 8,915 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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