Events

Recall of Device Recall BD Ophthalmic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BD Opthalmic Systems.

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
    34715
  • Event Risk Class
    Class 2
  • Event Number
    Z-0613-06
  • Event Initiated Date
    2006-02-28
  • Event Date Posted
    2006-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44530
  • 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
    Knife, Ophthalmic - Product Code HNN
  • Reason
    Product labeled as a 2.8 mm may contain a 3.2 mm xstar slit knife.
  • Action
    BD Ophthalmic notifIed customers by telephone on 2/28/06 requesting users to examine product and return mislabeled product.

Device

Device Recall BD Ophthalmic
  • Model / Serial
    Lot Number: 5335524
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Belgium
  • Product Description
    BD Xstar Bevel Up Slit Knife 2.8mm , Sterile || Catalog Number: 373728
  • Manufacturer
    BD Opthalmic Systems

Manufacturer

BD Opthalmic Systems
  • Manufacturer Address
    BD Opthalmic Systems, 411 Waverley Oaks Road, Waltham MA 02452-8448
  • Source
    USFDA