Events

Recall of Device Recall Visica

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sanarus Medical 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
    26582
  • Event Risk Class
    Class 2
  • Event Number
    Z-1008-03
  • Event Initiated Date
    2003-06-16
  • Event Date Posted
    2003-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27932
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Corrosion in stainless steel device shaft that allows argon gas to escape from device during a cryoablation procedure.
  • Action
    A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.

Device

Device Recall Visica
  • Model / Serial
    Lot # C030404
  • Product Classification
    General and Plastic Surgery Devices
  • Distribution
    Product was released for distribution to 12 consignees across the United States, including US states: GA, WI, TX and NY. A total of 41 units from the lot had been shipped to these consignees. The recall was extended to the user level who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    Sanarus Visica¿ Treatment System (disposable), Model/Product Code: VP-0500 (single)
  • Manufacturer
    Sanarus Medical Inc

Manufacturer

Sanarus Medical Inc
  • Manufacturer Address
    Sanarus Medical Inc, 5880 West Las Positas Suite 52, Pleasanton CA 95488
  • Source
    USFDA