Events

Recall of PRISMA SET/PRE SET

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

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
    50628
  • Event Risk Class
    II
  • Event Initiated Date
    2005-12-14
  • 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
    The manufacturer has become aware of several events of access pressure pod leakage when unloading the prisma sets from the prisma system after disconnecting the patient.

Device

PRISMA SET/PRE SET
  • Model / Serial
    Model Catalog: (Lot serial: 05F0864P); Model Catalog: (Lot serial: 05G1366G); Model Catalog: (Lot serial: 05F3098G); Model Catalog: (Lot serial: 05F2387G); Model Catalog: (Lot serial: 05F1574); Model Catalog: (Lot serial: 05F1573G); Model Catalog: (Lot serial: 05F0966); Model Catalog: (Lot serial: 05F0865); Model Catalog: (Lot serial: 05F0763A); Model Catalog: (Lot serial: 05D1571); Model Catalog: (Lot serial: 05A0754P); Model Catalog: (Lot serial: 04K2692P); Model Catalog: (Lot serial: 05G0760G); Model Catalog: (Lot serial: 05G0556G); Model Catalog: (Lot serial: 05F1675G)
  • Product Description
    GAMBRO PRISMA SETS (M100)
  • Manufacturer
    GAMBRO INC.

Manufacturer

GAMBRO INC.