Events

Recall of Device Recall Fischer Cone Biopsy Excisor

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    79828
  • Event Risk Class
    Class 2
  • Event Number
    Z-1879-2018
  • Event Initiated Date
    2018-03-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163620
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrocautery, gynecologic (and accessories) - Product Code HGI
  • Reason
    Products have been packaged with an incorrect product size.
  • Action
    On March 26, 2018 CooperSurgical mailed medical device recall notification letters to affected customers. Customers were instructed to: please discontinue use of any of the lots listed in the table above and complete the attached Acknowledgement and Receipt Form to schedule refund or exchange. If you have supplied or transferred any potentially affected product to another facility or organization, please let them know of the recall by providing a copy of this letter. If you have any further questions, please feel free to contact CooperSurgical at recall@coopersurgical.com.

Device

Device Recall Fischer Cone Biopsy Excisor
  • Model / Serial
    Lot number: 212074
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain
  • Product Description
    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Manufacturer Address
    CooperSurgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA