The Recall Desk

FDA (Devices) recall action 74934

Sorin Group USA, Inc. recalled 2 products on 2016-09-14

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
2016-09-14
Critical
0
Units
1,405

Why these products were recalled

Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-09-14

    Sorin Aortic Arch Cannula Recalled for Improper Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulas because the tip angle is less than the required 45 or 90 degrees.

    Product
    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flex
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2016-09-14

    Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect

    Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.

    Product
    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff
    Category
    Distribution
    3 states