Events

Recall of Device Recall Medivance ArcticGel Neonatal Pad

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. Bard, 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
    74609
  • Event Risk Class
    Class 3
  • Event Number
    Z-2345-2016
  • Event Initiated Date
    2016-06-30
  • Event Date Posted
    2016-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148027
  • 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
    System, thermal regulating - Product Code DWJ
  • Reason
    An internal review of an available product found that the information for use only contained english and japanese languages when a ce-marked 23 language version was expected.
  • Action
    A Customer Communication Correction Letter was sent to customers on June 30, 2016. The letter requested that they examine inventory and remove the original IFU and substitute a copy of the IFU that was included with the Correction letter. The letter also requested a sub-recall, and included a reply form which was to be completed and returned. If you have any further questions please call (401) 825-8690.

Device

Device Recall Medivance ArcticGel Neonatal Pad
  • Model / Serial
    Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
  • Product Description
    Medivance ArcticGel Neonatal Pad || The pad is designed to fit into an incubator and provide whole body cooling for patients.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA