Events

Recall of Device Recall VAPR TRIPOLAR 90" Degree Suction Electrodes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Mitek, Inc., a Johnson & Johnson Co..

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
    72703
  • Event Risk Class
    Class 2
  • Event Number
    Z-0479-2016
  • Event Initiated Date
    2015-11-23
  • Event Date Posted
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142122
  • 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
    Mitek identified that on vapr tripolar 90 degree suction electrode the ablation and coagulation buttons are colored incorrectly. the wiring for each button function was confirmed as correct and the non-conformance impacted button color only.
  • Action
    DePuy sent an Urgent Field Safety Notice dated November 23, 2015, mailed FEDEx to all affected Customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to take the following steps: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located in your facility. 2. Review, complete, sign and return the attached business reply form in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any potentially affected product has been forwarded to another facility, contact the firm. 5. Keep a copy of this notice. For further questions please call (508) 880-8100.

Device

Device Recall VAPR TRIPOLAR 90" Degree Suction Electrodes
  • Model / Serial
    U1509202 and U1509162
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.
  • Product Description
    VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Manufacturer Address
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Drive, Raynham MA 02767-5199
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA