Events

Recall of Device Recall BRACCO ACIST

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acist Medical Systems.

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
    29159
  • Event Risk Class
    Class 2
  • Event Number
    Z-1002-04
  • Event Initiated Date
    2004-05-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33232
  • 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
    Injector And Syringe, Angiographic - Product Code DXT
  • Reason
    Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
  • Action
    Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.

Device

Device Recall BRACCO ACIST
  • Model / Serial
    Lot # 0584B
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Product Description
    AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Manufacturer Address
    Acist Medical Systems, 7450 Flying Cloud Dr Ste 150, Eden Prairie MN 55344-3720
  • Source
    USFDA