Events

Recall of Zinnanti Injector 2.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Catheter Research, 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
    35241
  • Event Risk Class
    Class 2
  • Event Number
    Z-1077-06
  • Event Initiated Date
    2006-04-24
  • Event Date Posted
    2006-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45593
  • 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
    Cannula, Manipulator/Injector, Uterine - Product Code LKF
  • Reason
    The uterine stop component was not included with the device.
  • Action
    Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product.

Device

Zinnanti Injector 2.0
  • Model / Serial
    Lot M20772.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Minnesota and Spain.
  • Product Description
    Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.
  • Manufacturer
    Catheter Research, Inc

Manufacturer

Catheter Research, Inc
  • Manufacturer Address
    Catheter Research, Inc, 6131 W 80th St, Indianapolis IN 46278-1344
  • Source
    USFDA