Events

Recall of Device Recall NovaPlus

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
    70286
  • Event Risk Class
    Class 2
  • Event Number
    Z-1301-2015
  • Event Initiated Date
    2015-01-26
  • Event Date Posted
    2015-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133302
  • 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
    Pack, hot or cold, disposable - Product Code IMD
  • Reason
    Products without expiration date have the remote potential for minor burn.
  • Action
    CooperSurgical issued Recall Notification letter on January 26, 2015, via Fedex confirmed receipt delivery, to all affected customers. Customers were requested to review inventory and return/destroy product that does not have a expiration and lot number. A fax back form to be returned. Customers with questions should call 203.601.5200. CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement.

Device

Device Recall NovaPlus
  • Model / Serial
    Products without an expiration date and lot number
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
  • Product Description
    NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 || NovaPlus Brand Liquid Heal Warmer. Item #V6393 || Single Use and Disposable || To provide gentle heat to increase blood flow and enhance infant blood sample collection
  • 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