Events

Recall of EMPTYSTERILE I.V.SOLUTION TRANSFER CONTAINERS AND FILL/PUMP TUBING SETS

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

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
    32294
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-06
  • 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
    Autocomp6 autocomp6 xp and autocomp6 xps high speed compounders may not be able to maintain the fill accuracy requirements for the compounded bags as outlined in the user's manual. therefore the patient receiving the compounded bag may both receive the correct quantity of individual parenteral nutrition solutions or the correct overall quantity of parenteral nutrition solutions.

Device

EMPTYSTERILE I.V.SOLUTION TRANSFER CONTAINERS AND FILL/PUMP TUBING SETS
  • Model / Serial
    Model Catalog: 58741 (Lot serial: ALL LOTS); Model Catalog: 58740 (Lot serial: ALL LOTS); Model Catalog: 58785 (Lot serial: ALL LOTS); Model Catalog: 66715 (Lot serial: ALL LOTS); Model Catalog: 66710 (Lot serial: ALL LOTS); Model Catalog: 66330 (Lot serial: ALL LOTS); Model Catalog: 66325 (Lot serial: ALL LOTS); Model Catalog: 58742 (Lot serial: ALL LOTS); Model Catalog: 58750 (Lot serial: ALL LOTS); Model Catalog: 58753 (Lot serial: ALL LOTS); Model Catalog: 58754 (Lot serial: ALL LOTS); Model Catalog: 58781 (Lot serial: ALL LOTS); Model Catalog: 66005 (Lot serial: ALL LOTS); Model Catalog: 66010 (Lot serial: ALL LOTS); Model Catalog: 66015 (Lot serial: ALL LOTS); Model Catalog: 66020 (Lot serial: ALL LOTS); Model Catalog: 66025 (Lot serial: ALL LOTS); Model Catalog: 66030 (Lot serial: ALL LOTS); Model Catalog: 66035 (Lot serial: ALL LOTS); Model Catalog: 66315 (Lot serial: ALL LOTS); Model Catalog: 66310 (Lot serial: ALL LOTS)
  • Product Description
    EMPTYSTERILE I.V.SOLUTION TRANSFER CONTAINERS
  • Manufacturer
    HEALTHMARK SERVICES LTD.

Manufacturer

HEALTHMARK SERVICES LTD.
  • Manufacturer Address
    ST. LAURENT
  • Source
    HC