Events

Recall of Device Recall TAMPA CATHETER 5 French 33 cm.

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
    68317
  • Event Risk Class
    Class 2
  • Event Number
    Z-1782-2014
  • Event Initiated Date
    2014-05-13
  • Event Date Posted
    2014-06-11
  • 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=127327
  • 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
    Sterility of the device may be compromised due to unsealed pouch.
  • Action
    Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.

Device

Device Recall TAMPA CATHETER 5 French 33 cm.
  • Model / Serial
    Lot 141525
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
  • Product Description
    Cooper Surgical TAMPA CATHETER 5 French 33 cm. || Intended for Hysterosonography. || Model Number: 61-2005
  • 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