Events

Recall of 2 MHZ Waterproof OB Probe

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
    79213
  • Event Risk Class
    Class 2
  • Event Number
    Z-1131-2018
  • Event Initiated Date
    2017-10-06
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161662
  • 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
    Monitor, ultrasonic, fetal - Product Code KNG
  • Reason
    The 2mhz prove was incorrectlhttp://cts.Fda.Gov/division-tracking/images/trash.Pngy labeled as a 3mhz probe.
  • Action
    CooperSurgical sent an Urgent Medical Device Recall letter dated October 6, 2017 to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for replacement. If you have any further questions please feel free to contact me at 203.601.5200.

Device

2 MHZ Waterproof OB Probe
  • Model / Serial
    SIN 2017070001 SIN 2017070008 SIN 2017070002 SIN 2017070009 SIN 2017070003 SIN 2017070010 SIN 2017070004 SIN 2017070011 SIN 2017070005 SIN 2017070012 SIN 2017070006 SIN 2017070013 SIN 2017070007
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of ( Canada and England)
  • Product Description
    Cooper Surgical 2 MHZ Waterproof OB Probe || Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.
  • 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