The Recall Desk

FDA (Devices) recall action 66112

Edwards Lifesciences, LLC recalled 2 products on 2013-11-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-11-13
Critical
0
Units
220

Why these products were recalled

Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2013-11-13

    Edwards Lifesciences Recalls Aortic Perfusion Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of aortic perfusion cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures.…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-11-13

    Edwards Lifesciences Recalls Fem-Flex Femoral Arterial Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of Fem-Flex Femoral Arterial Cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial…
    Category
    Distribution
    0 states