Events

Recall of Device Recall bvi Beaver Xstar Safety Slit Knife

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beaver-Visitec International Inc..

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
    78789
  • Event Risk Class
    Class 2
  • Event Number
    Z-0503-2018
  • Event Initiated Date
    2017-11-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160527
  • 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, surgical - Product Code EMF
  • Reason
    The firm received 200 reports in which the protective shield was retracted.
  • Action
    The firm disseminated their safety advisory notices on 11/03/2017 by email and visit. The letter identified the affected product, problem and actions to be taken. The firm requested the following action:"Prior to opening the Tyvek tray, please visually confirm that the plastic shield is not retracted and the activation slider is fully engaged."

Device

Device Recall bvi Beaver Xstar Safety Slit Knife
  • Model / Serial
    Batch Numbers: 3180336 3181395 3183925 3184461 3183518 3187183 3187940 3189616 3190463 3192521 3193360 3194101 3199801 3200589 3201368 3201959 3202091 3202764 3203228 3204381 3205075 3205511 3205828 3207499 3208102 3211276 3215327 3218819 3218144 3220074 3221091 3221092 3223818 3223055 3223115 3224020 3225234
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
  • Product Description
    bvi Beaver(R) Xstar(R) Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 || Product Usage: || Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
  • Manufacturer
    Beaver-Visitec International Inc.

Manufacturer

Beaver-Visitec International Inc.
  • Manufacturer Address
    Beaver-Visitec International Inc., 411 Waverley Oaks Rd Ste 229, Waltham MA 02452-8422
  • Manufacturer Parent Company (2017)
    Tpg Capital Management L.P.
  • Source
    USFDA