Events

Recall of RITA StarBurstXL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rita Medical Systems, 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
    37742
  • Event Risk Class
    Class 2
  • Event Number
    Z-0752-2007
  • Event Initiated Date
    2007-04-03
  • Event Date Posted
    2007-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51443
  • 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
    Electro-surgical Device - Product Code GEI
  • Reason
    The product may have a cracked tray which can compromise the sterility of the product.
  • Action
    Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.

Device

RITA StarBurstXL
  • Model / Serial
    Part number: 700-101317, Lot number: 22330, 22793, 23297, 23306, 24413, 24655, 25120, 25355, 25425, 25545, 25546, 25547, 25632, 25747, 25748, 25806, 25807, 25808, 25850, 25851, 25876, 25940, 25941, 25971, 25979, 25980, 25981, 26145, 26146, 26456, 26457, 26458, 26496, 26555, 26556, 26581, 26663, 26664, 26930, 26931, 26986, 26987, 27068, 27158, 27168, 27326, 27401, 27437, 27554, 27555, 27711, 27818, 27874, 28189, 28200, 28314, 28462, 28471, 28474, 28556, 28557, 28578, 28635, 28636, 28637, 28709, 28902, 28903, 28965, 28967, 28979, 29041, 29052, 29153, 29250, 29277, 29278, 29426, 29542, 29543, 29670, 29775, 29793 and 29794 Part number 700-101317J (Japanese distribution), Lot numbers 26714, 26715, 27327, 27328, 27329, 27526, 27626, 27969, 28084, 28190, and 28250.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
  • Product Description
    RITA¿ Starburst¿ XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
  • Manufacturer
    Rita Medical Systems, Inc.

Manufacturer

Rita Medical Systems, Inc.
  • Manufacturer Address
    Rita Medical Systems, Inc., 1 Horizon Way, Manchester GA 31816-1749
  • Source
    USFDA