Events

Recall of Hollow Fiber Oxygenator

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
    49378
  • Event Risk Class
    Class 2
  • Event Number
    Z-2469-2008
  • Event Initiated Date
    2008-08-08
  • Event Date Posted
    2008-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73229
  • 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 - Product Code DTZ
  • Reason
    Under certain conditions, venous reservoir on oxygenator may allow air into the system.
  • Action
    The firm sent out a notification letter, by certified letter, on Aug 8,2008. Instructions on how to prevent air from entering the system were provided. Sorin Group USA, Inc. can reached at 1-303-467-6306.

Device

Hollow Fiber Oxygenator
  • Model / Serial
    Lot No: 0501210038, and 0710290112.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NC
  • Product Description
    Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmonary bypass circuits as a device to replace the function of the lungs in order to control the arterial/venous temperature and as a venous blood reservoir
  • 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