The Recall Desk

FDA (Devices) recall action 73365

Bard Peripheral Vascular Inc recalled 2 products on 2016-03-16

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
2016-03-16
Critical
0
Units
6,476

Why these products were recalled

Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.

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

  • HighFDA (Devices)··2016-03-16

    Bard Denali Filter Delivery System Recalled for Cracking Stop Cocks

    Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.

    Product
    Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2016-03-16

    Bard Denali Filter Delivery Systems Recalled for Cracking Stop Cocks

    Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.

    Product
    Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
    Category
    Distribution
    49 states