Recall Z-0398-2016— Edwards Lifesciences, LLC

Name: FDA recall Z-0398-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-04

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2015-11-04, terminated 2017-02-10. It names one FDA 510(k) clearance: K120072. Product: Thin-Flex Venous Cannula, Model Number:TF292902A. Reason: 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..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-11-04
Terminated: 2017-02-10
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K120072 — VENOUS DRAINAGE CANNULA WITH DURAFLO COATINGEdwards Lifesciences, LLC·cleared 2012-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.