Events

Recall of OMNIFLEX DIAPHRAGM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOPERSURGICAL 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
    19409
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-07
  • 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
    Coopersurgical discovered a packaging error in a single lot number of the milex diaphragm product line. the labels applied to this lot of packaging may not accurately reflect the size of the product contained in the package. the label may indicate a 5mm larger size than the actual size of the product. the correct size of the diaphragm is molded into the device.

Device

OMNIFLEX DIAPHRAGM
  • Model / Serial
    Model Catalog: MXWF65 (Lot serial: Lot 113367)
  • Product Description
    Milex Wide-Seal Silicone Diaphragm Kit
  • Manufacturer
    COOPERSURGICAL INC.

Manufacturer

COOPERSURGICAL INC.