Events

Recall of CYSTOSCOPY IRRIGATION SET

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

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
    133485
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-26
  • 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 tyvek cover (white lid) may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package. the opening packaging of the affected product provides the opportunity for infectious agents and particulates matter to enter into the irrigation system and be transferred into the urinary tract.

Device

CYSTOSCOPY IRRIGATION SET
  • Model / Serial
    Model Catalog: 06544-XX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 06543-XX (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    Cystoscopy Irrigation Set
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HC