Events

Recall of Device Recall Autotransfusion apparatus

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
    32561
  • Event Risk Class
    Class 2
  • Event Number
    Z-1071-05
  • Event Initiated Date
    2005-06-22
  • Event Date Posted
    2005-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40344
  • 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
    Apparatus, Autotransfusion - Product Code CAC
  • Reason
    Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
  • Action
    Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005

Device

Device Recall Autotransfusion apparatus
  • Model / Serial
    Catalog Number: 007214100. Lot Numbers 0511600001, 0511600002, 0512300001, 0512300002, 0513000002, 0513000001, 0513700001, 0513700002, 0514400002, 0514400003, 0514400004, 0515100185.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.
  • Product Description
    ASY Brat 2 Procedure Set
  • Manufacturer
    Cobe Cardiovascular, Inc

Manufacturer

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