Events

Recall of Device Recall Sorin Group Smart Perfusion Pack EPack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LivaNova USA.

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
    79000
  • Event Risk Class
    Class 3
  • Event Number
    Z-0664-2018
  • Event Initiated Date
    2017-12-19
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161062
  • 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
    Tubing, pump, cardiopulmonary bypass - Product Code DWE
  • Reason
    The product is labeled with the incorrect expiration date.
  • Action
    The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.

Device

Device Recall Sorin Group Smart Perfusion Pack EPack
  • Model / Serial
    Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to one consignee in LA.
  • Product Description
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
  • Manufacturer
    LivaNova USA

Manufacturer

LivaNova USA
  • Manufacturer Address
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA