Events

Recall of ON-Q C-BLOC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDQUEST MEDICAL 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
    82530
  • Event Risk Class
    I
  • Event Initiated Date
    2012-06-22
  • 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
    I-flow recently determined that in a small quantity of on-q pumps with ondemand the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. in this condition the patient may receive continuous infusion at a rate greater than expected.

Device

ON-Q C-BLOC
  • Model / Serial
    Model Catalog: CB003 (Lot serial: Products having a 10-digit); Model Catalog: CB006 (Lot serial: are NOT impacted by this); Model Catalog: CB003 (Lot serial: lot#s that is >0200521454); Model Catalog: CB006 (Lot serial: lot#s that is >0200521454); Model Catalog: CB003 (Lot serial: (ie. 0200521455 and greater)); Model Catalog: CB006 (Lot serial: Products having a 10-digit); Model Catalog: CB003 (Lot serial: recall.); Model Catalog: CB006 (Lot serial: recall.); Model Catalog: CB003 (Lot serial: are NOT impacted by this); Model Catalog: CB006 (Lot serial: (ie. 0200521455 and greater))
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    ON Q C-BLOC WITH ONDEMAND (MODEL # CB003 & MODEL # CB006)
  • Manufacturer
    MEDQUEST MEDICAL INC.

Manufacturer

MEDQUEST MEDICAL INC.