Events

Recall of CooperSurgical

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
    69636
  • Event Risk Class
    Class 2
  • Event Number
    Z-0484-2015
  • Event Initiated Date
    2014-10-27
  • Event Date Posted
    2014-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131206
  • 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
    Outer box is mislabeled as p/n r2010- large radius loop electrode instead of p/n r1010- medium radius loop electrode.
  • Action
    CooperSurgical issued recall letter dated October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form. Customers with questions were instructed to call 203-601-5200.

Device

CooperSurgical
  • Model / Serial
    Lot 159621 Exp Date: 2017-05
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
  • Product Description
    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 || Model Number(s): R2010 || Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Manufacturer Address
    CooperSurgical, Inc., 75 Vista Pl, Trumbull CT 06611-3934
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA