Events

Recall of NOVAPLUS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company / Medical Division.

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
    30137
  • Event Risk Class
    Class 2
  • Event Number
    Z-0037-05
  • Event Date Posted
    2004-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35239
  • 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
    Electrode, Electrosurgical - Product Code JOS
  • Reason
    Improper wire placement from the patient plate to the esu connector plug results in an intermittent displacement connection.
  • Action
    A recall notification letter dated 09/30/2004 was sent to Hospitals and Health Care Distributors instructing consignees to immedately remove all effective product from lot 2007-06 HP.

Device

NOVAPLUS
  • Model / Serial
    Lot 2007-06 HP
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The subject product lot was distributed to the following key 3M distributors: Owens & Minor, Cardinal Health, McKesson, Professional Health Supply, and the Burrows Company.
  • Product Description
    NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Manufacturer Address
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, South St Paul MN 55411
  • Source
    USFDA