Events

Recall of Device Recall Human tissue for transplantation.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DCI Donor Services Tissue Services Division.

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
    25493
  • Event Risk Class
    Class 2
  • Event Number
    Z-0677-03
  • Event Initiated Date
    2002-08-20
  • Event Date Posted
    2003-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25925
  • 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
    Human tissue was procured from donor using non-sterile instruments.
  • Action
    Consignee was notified by memorandum on 8/20/2002.

Device

Device Recall Human tissue for transplantation.

Manufacturer

DCI Donor Services Tissue Services Division
  • Manufacturer Address
    DCI Donor Services Tissue Services Division, 1714 Hayes Street, Nashville TN 37203
  • Source
    USFDA