Events

Recall of Pulmonary heart valve allograft, human tissue for transplantation.

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

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
    25449
  • Event Risk Class
    Class 2
  • Event Number
    Z-0525-03
  • Event Initiated Date
    2002-12-19
  • Event Date Posted
    2003-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25847
  • 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
    Heart-Valve, Allograft - Product Code MIE
  • Reason
    Recalling firm distributed a heart valve from donor whose sera was found potentially positive for hepatitis c.
  • Action
    Firm notified consignee by phone and letter 12/19/02 and requested valve to be returned.

Device

Pulmonary heart valve allograft, human tissue for transplantation.
  • Model / Serial
    01-0293HV-02
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Product was shipped to one hospital in NY
  • Product Description
    Pulmonary heart valve allograft, human tissue for transplantation.
  • Manufacturer
    LifeNet

Manufacturer

LifeNet
  • Manufacturer Address
    LifeNet, 5809 Ward Ct, Virginia Beach VA 23455
  • Source
    USFDA