Events

Recall of Custom heart lung perfusion packs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cobe Cardiovascular, 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
    33842
  • Event Risk Class
    Class 2
  • Event Number
    Z-0265-06
  • Event Initiated Date
    2005-10-06
  • Event Date Posted
    2005-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42536
  • 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
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line - Product Code DTM
  • Reason
    One way valve in the heart lung pack assembly may be missing.
  • Action
    Consignees notified by letter on 10/06/2005.

Device

Custom heart lung perfusion packs
  • Model / Serial
    210 unique catalog numbers with 779 unique lot numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.
  • Product Description
    Custom heart lung perfusion packs
  • Manufacturer
    Cobe Cardiovascular, Inc

Manufacturer

Cobe Cardiovascular, Inc
  • Manufacturer Address
    Cobe Cardiovascular, Inc, 14401 W 65th Way, Arvada CO 80004-3524
  • Source
    USFDA