Z-1111-2013Class II

Edwards Lifesciences Duraflo coated Femoral Cannula

Name: Z-1111-2013 Edwards Lifesciences Duraflo coated Femoral Cannula
Creator: Edwards Lifesciences, LLC
Published: 2013-03-14
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-03-14 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and... on 2013-03-14. FDA classified it as Class II and gives the reason as "Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1111-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-14
Posted: 2013-04-14
Terminated: 2016-03-08
Recalling firm: Edwards Lifesciences LLC
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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Edwards Lifesciences sent an Urgent Field Safety Notice letter dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of any affected product remaining in inventory and to return any unused devices to Edwards. A completed Acknowledgement Form should be faxed to Edwards at 800-422-9329 within three days of receiving the notice. Questions regarding the recall should be directed to Edwards Customer Services at 800-424-3278, 6:00AM - 4:30PM PST.
Quantity in commerce: 379 units
Distribution: USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
Product codes and lots: Model DIIFEMII018A, Lot 59337174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1111-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1111-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-14

Product code DWF

K123298Class IIFem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC / cleared 2013-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)