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Edwards Lifesciences, LLC recalls Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situati
Recalled April 24, 2013 · FDA recall Z-1111-2013 · Edwards Lifesciences
Hazard
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach. · FDA Class II
Units
379 units
Sold at
USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
Description
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
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.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →