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.
This recall has been terminated (originally issued April 14, 2013).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- March 14, 2013
- Posted
- April 14, 2013
- Terminated
- March 8, 2016
- Recall Number
- Z-1111-2013
- Quantity
- 379 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
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.
Distribution
USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
Lot / Code Info
Model DIIFEMII018A, Lot 59337174
Root Cause
Packaging process control
Action Taken
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.