Events

Recall of VAMP Direct Draw, Model VMP700 || Needleless cannula for sampling blood.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences AG.

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
    27871
  • Event Risk Class
    Class 2
  • Event Number
    Z-0242-04
  • Event Initiated Date
    2003-11-20
  • Event Date Posted
    2003-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30666
  • 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, Continuous Flush - Product Code KRA
  • Reason
    Seal integrity, sterility not assured.
  • Action
    Letter was sent to all customers requesting return of the unused lot on 11/20/2003.

Device

VAMP Direct Draw, Model VMP700 || Needleless cannula for sampling blood.
  • Model / Serial
    Lot 58151473
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    VAMP Direct Draw, Model VMP700 || Needleless cannula for sampling blood.
  • Manufacturer
    Edwards Lifesciences AG

Manufacturer

Edwards Lifesciences AG
  • Manufacturer Address
    Edwards Lifesciences AG, Parque Industrial Itabo, Km. 18.5 Carr. Sanchez, Haina, San Cristobal Dominican Republic
  • Source
    USFDA