Events

Recall of BD Visitec

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
    29568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1344-04
  • Event Initiated Date
    2004-09-16
  • Event Date Posted
    2004-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34133
  • 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
    Blade may become detached from the handle.
  • Action
    BD Medical initiated recall by telephone the week of 7/19/04 to direct accounts advising of the recall action, requesting return and providing replacement product.

Device

BD Visitec
  • Model / Serial
    Lot Numbers: 3182770, 3231212, 3234243, 3238890, 3274064, 3281592, 3318026, 3325843, 3330607, 3344597, 3344633, 4012982, 4033079, 4049076, 4069650, 4084089, 4084102, 4106845, 4125046, 4141947, 4147817
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) || REF 585240
  • Manufacturer
    BD Opthalmic Systems

Manufacturer

BD Opthalmic Systems
  • Manufacturer Address
    BD Opthalmic Systems, 411 Waverley Oaks Rd Ste 2229, Bldg. 2, Waltham MA 02452-8448
  • Source
    USFDA