The Recall Desk

FDA (Devices) recall action 71692

Cook Inc. recalled 3 products on 2015-08-12

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2015-08-12
Critical
0
Units
967,886

Why these products were recalled

Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

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

1–3 of 3

  • SevereFDA (Devices)··2015-08-12

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Separation

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because the tips may split or separate, potentially causing loss of function or complications.

    Product
    Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-08-12

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters due to reports of tip splits or separation, which may cause loss of function or complications.

    Product
    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascula
    Category
    Distribution
    3 states
  • SevereFDA (Devices)··2015-08-12

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling Beacon Tip Royal Flush Plus High-Flow Catheters due to reports of tip splits or separation that may cause loss of function or complications.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into th
    Category
    Distribution
    3 states