Events

Recall of PRISMA SET/PRE SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA 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
    44891
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-30
  • 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
    These conditions may occur when liquid is present on the male or female parts of the luer connector before connection (resulting for example from use of disinfectant or drops of priming or dialysate solution) and the wet connector is screwed by using the body of the luer connectors for tightening instead of screwing the coupling nut. under these circumstances the fluid on the cone can act as a lubricant and might lead to an over-tightening of the connection. the resulting luer connection may be difficult to disconnect and the male luer lock may break when applying a high mechanical force.

Device

PRISMA SET/PRE SET
  • Model / Serial
    Model Catalog: PRISMA TPE2000 SET (Lot serial: ALL LOTS); Model Catalog: PRISMA ST60 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMA ST100 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMA M100 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF20 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST100 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST60 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST150 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M60 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M150 SET (Lot serial: ALL LOTS); Model Catalog: OXIRIS (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF1400 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF1000 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M100 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX TPE 2000 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX TPE 1000 (Lot serial: ALL LOTS)
  • Product Description
    PRISMA SET
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC