Events

Recall of REVERSE BERMAN ANGIOGRAPHIC BALLOON CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    121376
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Arrow international has issued this voluntary field corrective action because the labeling for the products listed above formerly referenced renografin-76 contrast medium (viscosity of 8.4 centipoise) which is no longer available. arrow is in the process of updating the labeling for these products. in the meantime when choosing alternative contrast medium health care providers are instructed to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow setting specified in the current ifu.

Device

REVERSE BERMAN ANGIOGRAPHIC BALLOON CATHETER
  • Model / Serial
    Model Catalog: AI-07035 (Lot serial: ALL); Model Catalog: AI-07138 (Lot serial: ALL); Model Catalog: AI-07037 (Lot serial: ALL); Model Catalog: AI-07130 (Lot serial: ALL); Model Catalog: AI-07130-J (Lot serial: ALL); Model Catalog: AI-07131 (Lot serial: ALL); Model Catalog: AI-07137 (Lot serial: ALL); Model Catalog: AI-07136 (Lot serial: ALL); Model Catalog: AI-07135 (Lot serial: ALL); Model Catalog: AI-07134 (Lot serial: ALL); Model Catalog: AI-07133 (Lot serial: ALL); Model Catalog: AI-07132 (Lot serial: ALL)
  • Product Description
    REVERSE BERMAN ANGIOGRAPHIC BALLOON CATHETER
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.