Events

Recall of PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAMBRO DASCO S.P.A..

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
    111700
  • Event Risk Class
    II
  • Event Initiated Date
    2001-02-05
  • 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
    A drift in the production process of the prisma uabd sensor has been identified. this drift provokes a drift in the signal distribution response that may lead to a non-detection of air.

Device

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
  • Model / Serial
    Model Catalog: (Lot serial: serial # 962421 to 962713)
  • Product Description
    prisma CFM
  • Manufacturer
    GAMBRO DASCO S.P.A.

Manufacturer

GAMBRO DASCO S.P.A.