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.
Enforcement
- Recall Number
- Z-1111-2013
- Event ID
- 64782
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Edwards Lifesciences, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2013
- Initiation Date
- March 14, 2013
- Classification Date
- April 14, 2013
- Termination Date
- March 8, 2016
- Address
- 12050 Lone Peak Pkwy, N/A, Draper, UT, 84020-9414, United States
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.
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
Model DIIFEMII018A, Lot 59337174
USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
379 units