Recall of MAXILLOFACIAL PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDLINE CANADA CORPORATION.

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
    23751
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-15
  • Event Country
  • 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
    Bd medical has issued a recall on the bd insyte autoguard catheter cat. nos. 381433 and 38134 due to potential damage along the body of the catheter. a damaged catheter may lead to catheter leakage and the subsequent need for insertion of another catheter. the bd insyte catheter is a component in the medline maxillofacial pack dynj37293a.

Device

  • Model / Serial
    Model Catalog: DYNJ37293A (Lot serial: 14IB6293); Model Catalog: DYNJ37293A (Lot serial: 14HB7470)
  • Product Description
    Maxillofacial Pack
  • Manufacturer

Manufacturer