Events

Recall of Device Recall Visitec

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
    37533
  • Event Risk Class
    Class 3
  • Event Number
    Z-0672-2007
  • Event Initiated Date
    2007-03-02
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50690
  • 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
    cataract surgical instrument - Product Code KYG
  • Reason
    Mislabeled: carton label incorrectly labeled as ref 581618 (.40 x 16mm) , may contain product ref 581617 (.50 x 16mm).
  • Action
    BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.

Device

Device Recall Visitec
  • Model / Serial
    Lot Number: 6181868
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    BD Visitec Irrigating Cytosome, for use in cataract surgery. || Ref 581618
  • 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