Events

Recall of Model 750 24' MRI Reusable/Disposable Circuit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Impact Instrumentation, 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
    60767
  • Event Risk Class
    Class 2
  • Event Number
    Z-0717-2012
  • Event Initiated Date
    2011-10-19
  • Event Date Posted
    2012-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106429
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Reason
    Model 750 24' mri reusable/disposable circuit does not have a 510(k).
  • Action
    Impact sent Urgent Device Product Recall letters/return response forms dated 10/19/11 to their consignees. The letter asked customers to return the affected product listed to the address provided within 10 days of receipt of the notification letter. In order to receive proper credit for the returned product, customers should follow the instructions precisely, which includes completing and returning the Recall Tracking Form along with the affected product. If customers have no product to return, they should contact Alan Giordano at agiordano@impactii.com, to inform him of the status of the circuits.

Device

Model 750 24' MRI Reusable/Disposable Circuit
  • Model / Serial
    p/n 802-1750-05, no expiration ; 802-1750-24, five years
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- VA, CA, IL, NC, and TX.
  • Product Description
    Model 750 24' MRI Reusable/Disposable Circuit || Accessory for use with Model 750 Portable Ventilator
  • Manufacturer
    Impact Instrumentation, Inc.

Manufacturer

Impact Instrumentation, Inc.
  • Manufacturer Address
    Impact Instrumentation, Inc., 23 Fairfield Pl, West Caldwell NJ 07006-6206
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA