Events

Recall of Medrad Avanta Multipatient Disposable Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medrad 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
    33689
  • Event Risk Class
    Class 2
  • Event Number
    Z-0083-06
  • Event Initiated Date
    2005-09-20
  • Event Date Posted
    2005-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42289
  • 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
    Set, I.V. Fluid Transfer - Product Code LHI
  • Reason
    Stress crack on the stopcock.
  • Action
    The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.

Device

Medrad Avanta Multipatient Disposable Sets
  • Model / Serial
    Lot numbers 50627, 50628, 51069, 51070, 51071, and 51747
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and Italy.
  • Product Description
    Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Manufacturer Address
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA