Events

Recall of ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    28745
  • Event Risk Class
    II
  • Event Initiated Date
    2004-12-06
  • 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
    Certain lots of the ez-et product codes exhibit a structeral feature that may cause incomplete staple line to be formed and therefore not previde expected control of the tissue.

Device

ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER
  • Model / Serial
    Model Catalog: EZ45B (Lot serial: AND V); Model Catalog: EZ45G (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: EZ45B (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: EZ45G (Lot serial: V43C6F V43D7G); Model Catalog: EZ45B (Lot serial: V43C6F V43D7G); Model Catalog: EZ45G (Lot serial: V43D7H V43A0M V43A82); Model Catalog: EZ45B (Lot serial: V43D7H V43A0M V43A82); Model Catalog: EZ45G (Lot serial: EXCEPT V43A79 V43C6M); Model Catalog: EZ45B (Lot serial: EXCEPT V43A79 V43C6M); Model Catalog: EZ45G (Lot serial: AND V); Model Catalog: ET45B (Lot serial: V43C6M V43D7H V43A0M); Model Catalog: ET45B (Lot serial: EXCEPT V43A79); Model Catalog: ET45G (Lot serial: AND V); Model Catalog: ET45B (Lot serial: AND V); Model Catalog: ET45G (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: ET45B (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: ET45G (Lot serial: V43C6M V43D7H V43A0M); Model Catalog: ET45B (Lot serial: V43A82 V43C6F V43D7G); Model Catalog: ET45G (Lot serial: V43A82 V43C6F V43D7G); M
  • Product Description
    ENDOPATH THORACIC ELC ENDO. LINEAR CUT.
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.