Events

Recall of BD Microkeratome K3000 and K4000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson and Company.

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
    38739
  • Event Risk Class
    Class 2
  • Event Number
    Z-0066-2008
  • Event Initiated Date
    2007-08-09
  • Event Date Posted
    2007-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54235
  • 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
    Microkeratome - Product Code HMY
  • Reason
    Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea.
  • Action
    BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.

Device

BD Microkeratome K3000 and K4000
  • Model / Serial
    All serial numbers
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
  • Manufacturer
    Becton Dickinson and Company

Manufacturer

Becton Dickinson and Company
  • Manufacturer Address
    Becton Dickinson and Company, 411 Waverley Oaks Rd Ste 2229, Waltham MA 02452-8448
  • Source
    USFDA