Events

Recall of Arrow Multi-Lumen Central Venous Catheters

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Arrow International 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
    16809
  • Event Initiated Date
    2014-07-07
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Reason
    Arrow international, inc. ("arrow") is notifying customers that there is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (cvcs). 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 colour 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.
  • Action
    Manufacturer to issue advice regarding use

Device

Arrow Multi-Lumen Central Venous Catheters
  • Model / Serial
    Model: Models: CS-22854-E, CS-12854-E, CS-15854-E, CS-25854-E,CS-42854-E,ASK-22854-IM, Affected: Various
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc