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
    72107
  • Event Risk Class
    Class 3
  • Event Number
    Z-0105-2016
  • Event Initiated Date
    2015-09-01
  • Event Date Posted
    2015-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139883
  • 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
    Set, anesthesia, paracervical - Product Code HEE
  • Reason
    Kit label incorrect :labeled with lidocaine hci drug cartridges lidocaine hcl (2%) but contains vials lidocaine hcl (1%).
  • Action
    CooperSurgical issued an "Recall Notification" dated September 1, 2015, to all affected customers via FedEX with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers asked to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for a free replacement. Contact Product Surveillance at 203.601.5200 ext. 3300

Device

CooperSurgical
  • Model / Serial
    LOT 187889
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.
  • Product Description
    CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure || P/N 6061
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Manufacturer Address
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA