Events

Recall of Hemocor High Performance Hemoconcentrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medivators, 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
    72122
  • Event Risk Class
    Class 2
  • Event Number
    Z-2761-2015
  • Event Initiated Date
    2015-08-03
  • Event Date Posted
    2015-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139905
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Reason
    Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
  • Action
    Medivators sent an "Urgent Medical Device" recall letter, dated August 4, 2015, via email. The letter described the issue, identified the affected lot, requested the product be quarantined, and to contact Medivators for return instructions and credit or no-charge replacement product. A response form was requested to be returned to Medivators. Customers with questions can contact Medivators Product at 763-553-3348.

Device

Hemocor High Performance Hemoconcentrator
  • Model / Serial
    Lot 759491A
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of CA and MI.
  • Product Description
    Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide || The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.
  • Manufacturer
    Medivators, Inc.

Manufacturer

Medivators, Inc.
  • Manufacturer Address
    Medivators, Inc., 14605 28th Ave N, Plymouth MN 55447-4822
  • Manufacturer Parent Company (2017)
    Cantel Medical Corp.
  • Source
    USFDA