Events

Recall of BIOFLO PICC IR-145 KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NAVILYST MEDICAL 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
    107810
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-04
  • 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
    Navilyst medical is recalling picc catheters that contain valve(s) manufactured prior to july 15 2014. valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the picc catheter. use of the picc catheters that are subject to this recall may result in an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the picc catheter.

Device

BIOFLO PICC IR-145 KIT
  • Model / Serial
    Model Catalog: H965458840 (Lot serial: lot # 4830558); Model Catalog: H965458840 (Lot serial: lot # 4819459); Model Catalog: H965458840 (Lot serial: lot # 4797578); Model Catalog: H965458840 (Lot serial: lot # 4776149); Model Catalog: H965458840 (Lot serial: lot # 4753201); Model Catalog: H965952420 (Lot serial: > 10 numbers contact mfg); Model Catalog: H965952430 (Lot serial: > 10 numbers contact mfg); Model Catalog: H965952460 (Lot serial: > 10 numbers contact mfg); Model Catalog: H965952470 (Lot serial: > 10 numbers contact mfg); Model Catalog: M001454730 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454590 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454740 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454640 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454790 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454580 (Lot serial: >10 numbers contact mfg); Model Catalog: H965458410 (Lot serial: lot # 4814218); Model Catalog: H965458410 (Lot serial:
  • Product Description
    BioFlo PICC with Endexo and PASV Valve Technology IR-145 Kit
  • Manufacturer
    NAVILYST MEDICAL INC.

Manufacturer

NAVILYST MEDICAL INC.
  • Manufacturer Address
    MARLBOROUGH
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    HC