Events

Recall of LIGACLIP ERCA ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

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
    125438
  • Event Risk Class
    II
  • Event Initiated Date
    2004-06-07
  • 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
    Increased possibility of clip scissoring. clip scissoring can result in less than optimal clip formation that may or may not securely ligate tubular structures (i.E. vessels ducts). issue resolved.

Device

LIGACLIP ERCA ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
  • Model / Serial
    Model Catalog: ER320 (Lot serial: V4ZC1U); Model Catalog: ER320 (Lot serial: V4Z66C); Model Catalog: ER320 (Lot serial: V4Z66A); Model Catalog: ER320 (Lot serial: V4Z333); Model Catalog: ER320 (Lot serial: V4Z335); Model Catalog: ER320 (Lot serial: V4YZ8H); Model Catalog: ER320 (Lot serial: U4YX2Z); Model Catalog: ER320 (Lot serial: U4YX7Y); Model Catalog: ER320 (Lot serial: V4ZA0X); Model Catalog: ER320 (Lot serial: V4YZOC); Model Catalog: ER320 (Lot serial: V4ZA53)
  • Product Description
    ligaclip erca endoscope rotating mult.
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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