Events

Recall of ARROW VASCULAR POSITIONING SYSTEM (VPS) - BEDSIDE PROCEDURE KIT

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
    67749
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-13
  • 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 is recalling certain lots of the products referenced above due to reports clinicians have had difficulty maintaining a secure connection between the male luer of the tuohy borst adapter of the vascular positioning system stylet to the hub of the catheter. when the connection is not secure there is a possibility the connection will leak saline. this is most often discovered during initial flushing prior to insertion in which case a delay in treatment can occur while the health care provider locates a replacement device. in the unlikely event that the issue is discovered while the device is in use it could result in an inability to obtain a signal on the vps console. this would in turn necessitate removal and replacement of the catheter or an x-ray to confirm proper catheter placement.

Device

ARROW VASCULAR POSITIONING SYSTEM (VPS) - BEDSIDE PROCEDURE KIT
  • Model / Serial
    Model Catalog: VPS7220B (Lot serial: > 10 numbers contact mfg)
  • Product Description
    ARROW INTERNATIONAL VPS ACCESS KIT WITH TUOHY BORST COMPONENT
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.