Events

Recall of MED-RX EPIDURAL ANESTHESIA KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS.

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
    50811
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-19
  • 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
    Omega laboratories the supplier of sodium chloride identified an out-of-specification (oos) stability result for the ph value at the 12 month testing interval at 25 degrees celsius. found result is 7.6 (limit is 7.0). the product shelf life is 48 months and the lot is out-of-specification before expiry. med-rx anthesia kits contain this component.

Device

MED-RX EPIDURAL ANESTHESIA KIT
  • Model / Serial
    Model Catalog: 80-8005 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8004 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8006 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8018 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8022 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8023 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8025 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8026 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8033 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8034 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8042 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8060N (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8066 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8074 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8082 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 80-8040 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog:
  • Product Description
    MED-RX ANESTHESIA KIT
  • Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS

Manufacturer

CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS