Events

Recall of Device Recall Apex HP PHisio

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, 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
    60737
  • Event Risk Class
    Class 2
  • Event Number
    Z-0764-2012
  • Event Initiated Date
    2011-12-02
  • Event Date Posted
    2012-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106346
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Reason
    Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
  • Action
    Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.

Device

Device Recall Apex HP PHisio
  • Model / Serial
    All Lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA