FDAFDA · Food and drugs·Recall number Z-0135-2014
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. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Published November 13, 2013 · Recall initiated: August 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- Nationwide Distribution.
- Lot
- Lot number 59261626 expiry 06/01/15
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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