Recall Z-1466-2014— Edwards Lifesciences, LLC

Name: FDA recall Z-1466-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-09

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2014-04-09, terminated 2016-12-28. It names one FDA 510(k) clearance: K123298. Product: Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.. Reason: Potential for separation of dilator tips..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-04-09
Terminated: 2016-12-28
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K123298 — FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATINGEdwards Lifesciences, LLC·cleared 2013-03-15

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

Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.

Reason for recall

Potential for separation of dilator tips.

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