Events

Recall of ALARIS PK SYRINGE PUMP (REBRANDING)

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

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
    124935
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-01
  • 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
    Carefusion is aware of three significant events involving alaris syringe pumps administering into a high negative (vacuum) pressure patient line which resulted in a bolus. this condition may exist where the infusion line is shared with other high pressure medical cardiopulmonary bypass pumps or haemodialysis pumps.

Device

ALARIS PK SYRINGE PUMP (REBRANDING)
  • Model / Serial
    Model Catalog: 80053UN01 (Lot serial: MORE THAN SERIAL NUMBERS); Model Catalog: 80033UND1 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 80043UN01 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 80023UN01 (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Product Description
    ALARIS PK SYRINGE PUMP
  • Manufacturer
    BD SWITZERLAND SARL

Manufacturer

BD SWITZERLAND SARL