Events

Recall of Device Recall TUMEVAC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethox 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
    60374
  • Event Risk Class
    Class 3
  • Event Number
    Z-0271-2012
  • Event Initiated Date
    2011-03-25
  • Event Date Posted
    2011-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105194
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Reason
    Ethox tum-e-vac gastric lavage kit #2075, lot number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. the carton was labeled with a manufacturing date symbol and date of 2010/10. the ethox tum-e-vac gastric lavage kit #2075 does not have an expiration date.
  • Action
    Ethox International, Inc. sent an "URGENT DEVICE RECALL" letter dated March 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine if they have the affected product. Customers are to return the affected product to the firm by using UPS account 128959. Customers will be reimbursed for the returned goods. Additionally, a response form was enclosed for customers to complete and return. Contact the firm at (716) 842-4000 for questions regarding this recall.

Device

Device Recall TUMEVAC
  • Model / Serial
    REF 2075, LOT 031123255 [EXP SYMBOL] 2010/10
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including the states of California, Connecticut, Illinois, Ohio, and Virginia.
  • Product Description
    TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage
  • Manufacturer
    Ethox International, Inc.

Manufacturer

Ethox International, Inc.
  • Manufacturer Address
    Ethox International, Inc., 251 Seneca Street, Buffalo NY 14204
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    USFDA