Events

Recall of Fugo Blade Incising Tip Assembly

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medisurg Research & Management Corp.

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
    35738
  • Event Risk Class
    Class 2
  • Event Number
    Z-1224-06
  • Event Initiated Date
    2006-04-28
  • Event Date Posted
    2006-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46706
  • 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
    ophthalmic electrocautery - Product Code NCR
  • Reason
    No documentation to support shelf life/sterility.
  • Action
    On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.

Device

Fugo Blade Incising Tip Assembly
  • Model / Serial
    Lot numbers 01013786, 01017917, 01017918, 01017684 and 01017442
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including CA, CT, FL, GA, MA, NC, NY, OH, OR, PA, TX, and WI.
  • Product Description
    Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.
  • Manufacturer
    Medisurg Research & Management Corp

Manufacturer

Medisurg Research & Management Corp
  • Manufacturer Address
    Medisurg Research & Management Corp, 100 W Fornance Street, The Fugo Building, Norristown PA 19401
  • Source
    USFDA