Events

Recall of SINGLE-LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER KIT W/PLACEMENT WIRE

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
    58132
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-16
  • 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 received complaints for peel away sheaths flaring. the instructions for use included in the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. the use of a skin nick reduces the probability of sheath flare and subsequent complications. there is a remote possibility the device may cause a delay in treatment or minor vessel wall trauma and bleeding.

Device

SINGLE-LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER KIT W/PLACEMENT WIRE
  • Model / Serial
    Model Catalog: PR-05041 (Lot serial: > 10 numbers contact mfg); Model Catalog: PR-05042 (Lot serial: > 10 numbers contact mfg); Model Catalog: PI-01351-LS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01451-LS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01451-SS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01552-LS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01552-SS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01351-SS (Lot serial: > 100 numbers contact mfg)
  • Product Description
    SINGLE-LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER KIT;TWO-LUMEN PERIPHERALY INSERTED CENTRAL CATHETER KIT;PICC SELDINGER CONVERSION SET
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.