Device 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.
Z-1111-2013
Product summary
- Event
- Event 64782
- Status
- Terminated
- Classification
- Class II
- Quantity
- 379 units
- Official record key
device-enforcement:Z-1111-2013
Official wording
Reason: Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
Code information: Model DIIFEMII018A, Lot 59337174
Distribution pattern: USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
Derived failure modes
-
Unknown
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.