Events

Recall of ARROW-HOWES QUAD-LUMEN CENTRAL VENOUS CATHETERIZATION SET

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
    153867
  • Event Risk Class
    III
  • Event Initiated Date
    2014-05-28
  • 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
    There is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on certain central venous catheters. as an example the distal lumen may be printed with the word 'medial 18 ga' instead of 'distal 16ga'. the misprint does not impact the use of the product including use of individual lumens for infusion blood draws etc. the color coding of all hubs is correct and corresponds to the arrow system" white = proximal lumen grey = medial lumen 1 blue = medial lumen 2 brown = distal lumen.

Device

ARROW-HOWES QUAD-LUMEN CENTRAL VENOUS CATHETERIZATION SET
  • Model / Serial
    Model Catalog: CS-15854-E (Lot serial: NA); Model Catalog: CS-22854-E (Lot serial: NA); Model Catalog: CS-25854-E (Lot serial: NA); Model Catalog: CDA-45854-P1A (Lot serial: NA); Model Catalog: CDA-42854-P1A (Lot serial: NA)
  • Product Description
    CENTRAL VENOUS CATHETERIZATION KITS/SETS
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.