Events

Recall of STERILE EMPTY VIAL AND INJECTOR

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
    113436
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-08
  • 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
    Potential for the sterile empty 30 ml pca vial and injector (list no.6021-001) for use with hospira pca pump to leak from the injector at the mal luer lock end. leaking vials can result in drug waste during filling or delay in therapy if it occurs during administration. if the reported leakage had occured during use on a patient the most likely effect is a necessity to replace the pca vial at an unplanned time or administer supplemental medication.

Device

STERILE EMPTY VIAL AND INJECTOR
  • Model / Serial
    Model Catalog: 6021-XX (Lot serial: 01456R1); Model Catalog: 6021-XX (Lot serial: 02268R1); Model Catalog: 6021-XX (Lot serial: 02389R1); Model Catalog: 6021-XX (Lot serial: 02390R1); Model Catalog: 6021-XX (Lot serial: 06561R1); Model Catalog: 6021-XX (Lot serial: 07145R1); Model Catalog: 6021-XX (Lot serial: 01455R1); Model Catalog: 6021-XX (Lot serial: 13170R1); Model Catalog: 6021-XX (Lot serial: 15378R1); Model Catalog: 6021-XX (Lot serial: 15381R1); Model Catalog: 6021-XX (Lot serial: 16258R1); Model Catalog: 6021-XX (Lot serial: 13168R1)
  • Product Description
    Sterile Empty PCA Vial and Injector
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

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