Events

Recall of Device Recall bvi Beaver(R) EdgeAhead(R) Safety 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-0500-2018
  • 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=160463
  • 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    The firm received 200 reports in which the protective shield was retracted.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(R) EdgeAhead(R) Safety Knife
  • Model / Serial
    (a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976  (b) REF 378233; Batch numbers: 3191985 3204382 3225442
  • 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) EdgeAhead(R) Safety Knife, || (a) Sideport MVR .90mm 20G, REF 370531 || (b) Sideport Angled, .60mm (23G), REF 378233 || 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