Recall Z-1467-2014— Edwards Lifesciences, LLC

Name: FDA recall Z-1467-2014
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 with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.. 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 with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.

Reason for recall

Potential for separation of dilator tips.

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