Events

Recall of Device Recall Outback Percutaneous catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lumend 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
    29212
  • Event Risk Class
    Class 2
  • Event Number
    Z-0995-04
  • Event Initiated Date
    2004-05-18
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33334
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Reason
    Recall initiated after lumend received a report of a malfunction of an outback catheter in ohio.
  • Action
    Area Sales managers were contacted via phone conference on 05/18/04 and instructed to quarantine all outback catheters in their possession and notify all customers with any outback inventory to quarantine the product and make arrangements to retrieve the product from them.

Device

Device Recall Outback Percutaneous catheter
  • Model / Serial
    Model number OTB 1235, Dates of manufacture 11-2003, 03-2004 and 04-2004. Model number OTB 1245, Dates of manufacture 11-2003. 510(k) K032298.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Sent mainly to Area sales representatives.
  • Product Description
    LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
  • Manufacturer
    Lumend Inc

Manufacturer

Lumend Inc
  • Manufacturer Address
    Lumend Inc, 400 Chesapeake Dr, Redwood City CA 94063-4739
  • Source
    USFDA