The Recall Desk

FDA (Devices) recall action 71537

Volcano Corporation recalled 2 products on 2015-07-01

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
2015-07-01
Critical
0
Units
324

Why these products were recalled

During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture

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.

1–2 of 2

  • ModerateFDA (Devices)··2015-07-01

    Volcano PV .035 Catheter Recalled for Incorrect Shelf Life Labeling

    Volcano Corporation is recalling 162 PV .035 Catheters because they were labeled with incorrect shelf life dates during a relabeling procedure.

    Product
    Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to con
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-07-01

    Volcano Prestige Plus J-Tip Wire Recalled for Incorrect Shelf Life Labeling

    Volcano Corporation is recalling 162 Prestige Plus 185cm J-Tip pressure wires because they were labeled with incorrect shelf life dates during a relabeling procedure.

    Product
    Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure m
    Category
    Distribution
    0 states