The Recall Desk

FDA (Devices) recall action 71430

Cook Inc. recalled 2 products on 2015-07-29

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
2015-07-29
Critical
0
Units
1,322

Why these products were recalled

Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.

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)··2015-07-29

    Cook Inc. Recalls Flexor RTPS Guiding Sheaths Due to Dilator Length Complaints

    Cook Inc. is voluntarily recalling Flexor RTPS Guiding Sheaths and Ring Transjugular Intrahepatic Access Sets because users reported the included dilators were too long.

    Product
    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a…
    Category
    Distribution
    35 states
  • ModerateFDA (Devices)··2015-07-29

    Cook Inc. Recalls Ring Transjugular Intrahepatic Access Set Due to Dilator Length

    Cook Inc. is voluntarily recalling 661 Ring Transjugular Intrahepatic Access Sets and Flexor RTPS Introduce Sheaths because the dilators are too long.

    Product
    Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components…
    Category
    Distribution
    35 states