Events

Recall of Device Recall CooperSurgical H/S Catheter

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
    68754
  • Event Risk Class
    Class 2
  • Event Number
    Z-2570-2014
  • Event Initiated Date
    2014-07-03
  • Event Date Posted
    2014-09-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128603
  • 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
    Cannula, manipulator/injector, uterine - Product Code LKF
  • Reason
    Unsealed pouches.
  • Action
    Customer notification letter was sent on July 1, 2014 via UPS with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers may have on hand. For questions contact James Keller, Vice President, Regulatory Affairs/Quality Assurance at 203-601-5200.

Device

Device Recall CooperSurgical H/S Catheter
  • Model / Serial
    Lot 153914
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.
  • Product Description
    CooperSurgical H/S CATHETER (PART # 61-5007) || Intended for Hysterosonography/ Hysterosalpingography.
  • 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