Events

Recall of FILTER CONNECTING TUBING SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MENTOR WORLDWIDE LLC.

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
    15772
  • Event Risk Class
    II
  • Event Initiated Date
    2008-09-16
  • 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
    While performing packaging integrity validation package failures in the pt-5558aftu-ds and 5120-25 product packages occurred. byron medical determined that the risk to public health while minimal was sufficient to remove the product from the field.

Device

FILTER CONNECTING TUBING SET
  • Model / Serial
    Model Catalog: 211177 (Lot serial: >10 contact mfg); Model Catalog: 211182 (Lot serial: >10 contact mfg); Model Catalog: 211178 (Lot serial: >10 contact mfg); Model Catalog: 211179 (Lot serial: >10 contact mfg); Model Catalog: 211180 (Lot serial: >10 contact mfg); Model Catalog: 211181 (Lot serial: >10 contact mfg)
  • Product Description
    Aspiration infiltration tubing set
  • Manufacturer
    MENTOR WORLDWIDE LLC

Manufacturer

MENTOR WORLDWIDE LLC
  • Manufacturer Address
    SANTA BARBARA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC