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
    69642
  • Event Risk Class
    Class 3
  • Event Number
    Z-0488-2015
  • Event Initiated Date
    2014-10-27
  • Event Date Posted
    2014-12-01
  • 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=131211
  • 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
    Curette, suction, endometrial (and accessories) - Product Code HHK
  • Reason
    The product has been identified to contain an incorrect curette type.
  • Action
    CooperSurgical sent an Recall letter dated October 27, 2014, via UPS to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The subject device does not meet the required release specification as it contains an incorrect curette type. No adverse events or injuries have been reported to date in connection with the use of the CANNULA CURETTE. The event was discovered during internal investigation. Products that do not meet the above criteria are safe to use alongside the DFU guideline.The letter requests that customers return the recalled product for a full refund or exchange. If you have any further questions please feel free to call (203) 601.5200.

Device

CooperSurgical
  • Model / Serial
    Lot Code: 147234
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of NY, MO and NV.
  • Product Description
    Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 || The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.
  • 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