Events

Recall of Device Recall 2 S5 Mast Roller Pumps 85 with Double Holder

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
    57609
  • Event Risk Class
    Class 2
  • Event Number
    Z-0962-2011
  • Event Initiated Date
    2010-11-12
  • Event Date Posted
    2011-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96789
  • 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
    Cardiopulmonary Bypass Heart-Lung Machine Console - Product Code DTQ
  • Reason
    Touch screen may become unresponsive, inhibiting user input.
  • Action
    All affected US customers and distributors were notified by certified mail on Nov 12, 2010 via a Field Correction letter. They were told that they would be contacted by Sorin to arrange an appointment to inspect and replace affected touch screens on site. They were told that they could safely continue using their S5 systems in accordance with the Operator's Manual and previously supplied instructions until the inspection and necessary replacement had been completed. A customer response form was also included for completion and return to the firm. Customers can contact the firm if they have any questions.

Device

Device Recall 2 S5 Mast Roller Pumps 85 with Double Holder
  • Model / Serial
    Serial Numbers: 50E50153, 50E0154, 50K00332 to 50K00685.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004. || Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six 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