Events

Recall of Device Recall WETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED

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
    79908
  • Event Risk Class
    Class 2
  • Event Number
    Z-1539-2018
  • Event Initiated Date
    2018-02-26
  • 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=163908
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Incorrect tip was used during manufacturing of the osher thermodot marker. the markers have a needle tip instead of the proper flat tip.
  • Action
    On February 26, 2018, Beaver Visitec International Inc. emailed Product Recall Notices to affected customers. The letter identified the affected device and the reason for the recall. Customers were instructed to destroy affected product, provide evidence of the destruction, and complete a customer response form. Customers will receive a credit. Customers with questions regarding the recall may contact Customer Service at (866)906-8080.

Device

Device Recall WETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED
  • Model / Serial
    Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20  UDI: 30886158014899
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of OH, NY, FL, MN, and KS.
  • Product Description
    WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. || Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
  • 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