Events

Recall of Device Recall Smart Perfusion Pack

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
    54250
  • Event Risk Class
    Class 2
  • Event Number
    Z-1092-2010
  • Event Initiated Date
    2009-12-30
  • Event Date Posted
    2010-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87980
  • 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
    Perfusion tubing set - Product Code DWF
  • Reason
    Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
  • Action
    Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.

Device

Device Recall Smart Perfusion Pack
  • Model / Serial
    Lot Number: 0931300058.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Product Description
    Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of 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