Events

Recall of PER-Q-CATH MINI TRAY CENTRAL VENOUS CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD 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
    16555
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-21
  • 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
    Bard is notifying customers of incorrect lumen gauge size labeling on some per-q-cath products. bard identifies catheter size in two ways on this product by french size and gauge size. the french size is not affected and is correct for these products. product is not required to be removed as the product functions as intended and is manufactured according to design specifications with the correct french size designation.

Device

PER-Q-CATH MINI TRAY CENTRAL VENOUS CATHETER
  • Model / Serial
    Model Catalog: 4134115 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 4133105 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 4133135 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    PER-Q-CATH PICC
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.