Events

Recall of Unifusor Classic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CAS Medical Systems, 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
    49495
  • Event Risk Class
    Class 2
  • Event Number
    Z-0461-2009
  • Event Initiated Date
    2008-09-20
  • Event Date Posted
    2008-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73621
  • 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
    Pressure Infusor for I.V. - Product Code KZD
  • Reason
    Leaks: infusion cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. for further information, please contact the firm at 203-488-6056.
  • Action
    CAS Medical Systems notified accounts by letter dated 9/19/08 requesting return and sub-recall be conducted to their accounts. The letter was entitled "UNIFUSOR(R) INFUSION CUFFS AND PRIVATE LABEL (CASMED-MANUFACTURED) INFUSION CUFFS *** URGENT PRODUCT CORRECTION NOTICE." For further information, please contact the firm at 203-488-6056.

Device

Unifusor Classic
  • Model / Serial
    Lots: 21520608, 24710908, 29161308, 29171308, 31151308, 34471608, 2452208, and 43462308.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.
  • Product Description
    CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. || Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
  • Manufacturer
    CAS Medical Systems, Inc.

Manufacturer

CAS Medical Systems, Inc.
  • Manufacturer Address
    CAS Medical Systems, Inc., 44 E Industrial Rd, Branford CT 06405
  • Manufacturer Parent Company (2017)
    Cas Medical Systems Inc
  • Source
    USFDA