Events

Recall of HEPARIN LOCK FLUSH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANADIAN HOSPITAL SPECIALTIES 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
    80101
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-28
  • 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
    During testing of retention samples for heparin potency some lots failed anti-factor iia assay for potency. these syringes do not meet the usp monograph requirement for potency.

Device

HEPARIN LOCK FLUSH
  • Model / Serial
    Model Catalog: 50031-1000 (Lot serial: 94-057-9D); Model Catalog: E0400-35 (Lot serial: 94-057-9D); Model Catalog: 50051-1000 (Lot serial: >100 contact mfg); Model Catalog: 513604 (Lot serial: >100 contact mfg); Model Catalog: 60031-1000 (Lot serial: >100 contact mfg); Model Catalog: 60051-1000 (Lot serial: >100 contact mfg); Model Catalog: E0400-35 (Lot serial: >100 contact mfg); Model Catalog: 50031-1000 (Lot serial: >100 contact mfg); Model Catalog: 50051-1000 (Lot serial: >100 lot # contact manufact.); Model Catalog: 513604 (Lot serial: >100 lot # contact manufact.); Model Catalog: 60031-1000 (Lot serial: >100 lot # contact manufact.); Model Catalog: 60051-1000 (Lot serial: 94-057-9D); Model Catalog: 60031-1000 (Lot serial: 94-057-9D); Model Catalog: 513604 (Lot serial: 94-057-9D); Model Catalog: 50051-1000 (Lot serial: 94-057-9D); Model Catalog: 50031-1000 (Lot serial: 09-011-9D); Model Catalog: E0400-35 (Lot serial: 09-011-9D); Model Catalog: 60051-1000 (Lot serial: 09-011-9D); Model Catalog: 60031-100
  • Product Description
    HEPARIN LOCK FLUSH
  • Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD.

Manufacturer

CANADIAN HOSPITAL SPECIALTIES LTD.