Recall Z-1111-2013— Edwards Lifesciences, LLC

Name: FDA recall Z-1111-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-14

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2013-03-14, terminated 2016-03-08. It names one FDA 510(k) clearance: K123298. Product: Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.. Reason: Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-03-14
Terminated: 2016-03-08
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 Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.

Reason for recall

Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.

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