Events

Recall of Device Recall Edwards Lifesciences Suction Wand Model S099B

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
    65869
  • Event Risk Class
    Class 2
  • Event Number
    Z-1985-2013
  • Event Initiated Date
    2013-07-08
  • Event Date Posted
    2013-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120616
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Sorin group is recalling certain lots of edwards lifesciences suction wand model s099b due to presence of plastic particles inside the pouch.
  • Action
    On 7/8/13, customers and distributors were sent a "Field Safety Notice Product Recall" letter and requested to return unused Edwards Suction Wands found in the Perfusion Packs to the Sorin Group. Customers are to contact Sorin Group Customer Service at 1-800-650-6502 to receive instructions for returning the affected Edwards Suction Wand to Sorin. Customers were also advised to not discard affected product.

Device

Device Recall Edwards Lifesciences Suction Wand Model S099B
  • Model / Serial
    Model S099B
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

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