Recall of Device Recall THOMAS by Gardner Denver, MEDIPUMP(R) Aspirator, Model 1242

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gardner Denver Thomas 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
    71569
  • Event Risk Class
    Class 2
  • Event Number
    Z-2150-2015
  • Event Initiated Date
    2015-06-04
  • Event Date Posted
    2015-07-20
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-08-09
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Reason
    Vacuum pump may not perform to specification.
  • Action
    Gardner Denver Thomas sent an Important Medical Device Recall letter dated May 7, 2015 to affected distributors. The letter identified the affected products, problem and actions to be taken. For questions call your Customer Service Representative or Sales Representative or the Recall Coordinator at 920-451-6423.

Device

  • Model / Serial
    Serial numbers 3831-4200
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.
  • Product Description
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 || Product Usage: || medical aspirator
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Gardner Denver Thomas Inc, 4601 Central Ave, Monroe LA 71203-6003
  • Manufacturer Parent Company (2017)
  • Source
    USFDA