Events

Recall of VENISYSTEMS EXTENSION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPIRA.

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
    133346
  • Event Risk Class
    I
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    The extension set tubing that connects to the t adapter is not completly inserted into the receptive area of the t adapter the tubing disconnects from this jonction and results in a leakage of bood or solution.

Device

VENISYSTEMS EXTENSION SET
  • Model / Serial
    Model Catalog: (Lot serial: 69489vm); Model Catalog: (Lot serial: 64037vm); Model Catalog: (Lot serial: lot 64037vm); Model Catalog: (Lot serial: lot 69489vm); Model Catalog: (Lot serial: lot 70731vm); Model Catalog: (Lot serial: 70731vm)
  • Manufacturer
    HOSPIRA

Manufacturer

HOSPIRA
  • Manufacturer Address
    DONEGAL TOWN
  • Source
    HC