Events

Recall of COBE Autotransfusion set.

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
    36168
  • Event Risk Class
    Class 2
  • Event Number
    Z-1491-06
  • Event Initiated Date
    2006-08-04
  • Event Date Posted
    2006-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48127
  • 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
    autotransfusion set - Product Code CAC
  • Reason
    Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
  • Action
    Consignees were notified by telephone and e-mail on 08/04/2006.

Device

COBE Autotransfusion set.
  • Model / Serial
    COBE Product Code-ASCBFE22, Lot numbers: 0610100225, 0613000077, 0615700007, 0618600109, 0621300094-- COBE Product Code-ASCBE22, Lot Numbers: 0608000247, 0610800007, 0612300036, 0613000076, 0613600146, 0615700006, 0617200003, 0617800128, 0619200116, 0619900053, 0621300093--COBE Product Code- AS9E55, Lot Numbers: 0617200004, 0619900054, 0621300095-COBE Product Code- AS9E22, Lot Numbers: 0611600047, 0612300034, 0613000075, 0614300116, 0617200002, 0617800127, 0618600107, 0621300092--COBE Product Code- AS9E12, Lot Numbers: 0612300035, 0615000022, 0616400011, 0618600108, 0619900052-COBE Product Code- AS4E55, Lot Numbers: 0616400012, 0618600110- COBE Product Code-AS4E22, Lot Numbers: 0609400006, 0610100223, 0615700005, 0619900051-COBE Product Code- AS4E17, Lot Numbers: 0613600145, 0616400013, 0617200005, 0619900055.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in CA and OH
  • Product Description
    Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
  • Manufacturer
    Cobe Cardiovascular, Inc

Manufacturer

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