Events

Recall of Device Recall Bivona

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Portex, 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
    25650
  • Event Risk Class
    Class 2
  • Event Number
    Z-0927-03
  • Event Initiated Date
    2003-02-20
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26211
  • 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
    Instrument, Manual, General Obstetric-Gynecologic - Product Code KOH
  • Reason
    May have incorrectly printed graduation markings along the tube shaft.
  • Action
    A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.

Device

Device Recall Bivona
  • Model / Serial
    Lot 1134710
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, England and France
  • Product Description
    Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
  • Manufacturer
    Portex, Inc

Manufacturer

Portex, Inc
  • Manufacturer Address
    Portex, Inc, 5700 West 23rd Ave, Gary IN 46406
  • Source
    USFDA