Events

Recall of Device Recall WetField Hemostatic Eraser Bipolar 25G

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
    79915
  • Event Risk Class
    Class 2
  • Event Number
    Z-1801-2018
  • 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=163934
  • 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
    Products were packaged with incorrect labeling,.
  • Action
    On 2/26/18 Beaver-Visitec emailed product recall notices to affected customers. Customers were instructed to destroy the affected product, provide objective evidence of the product destruction, then complete and return the customer response form. Customers with questions regarding this recall may contact Customer Service at (866)906-8080.

Device

Device Recall WetField Hemostatic Eraser Bipolar 25G

Manufacturer

Beaver-Visitec International Inc.
  • Manufacturer Address
    Beaver-Visitec International Inc., 500 Totten Pond Rd, Waltham MA 02451-1916
  • Manufacturer Parent Company (2017)
    Tpg Capital Management L.P.
  • Source
    USFDA