Events

Recall of Valeant Pharmacueticals International SPAG 2 6000

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

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
    72630
  • Event Risk Class
    Class 2
  • Event Number
    Z-0674-2016
  • Event Initiated Date
    2015-09-21
  • Event Date Posted
    2016-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141692
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • Reason
    The serial i.D. label and some information in the operation manual for the spag 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
  • Action
    Valeant Pharmaceuticals International, Inc. sent Field Correction Notifications /Recall Stock Response Form dated September 22, 2015 through 2nd day air service to their customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. T The customers were requested to fill out and return the attached Recall Stock Response Form and return the form via email (bauschandlomb6443@stericycle.com or fax (844.782.5565). A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576) On October 7, 2015 a second field correction notification was sent to customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576). The updated notification clarified that the notification applies to all SPAG-2 6000 model units currently in the market.

Device

Valeant Pharmacueticals International SPAG 2 6000
  • Model / Serial
    SPAG 2 Unit, Product Part Number 6002
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution and Internationally to Canada and France.
  • Product Description
    Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
  • Manufacturer
    Valeant Pharmacueticals International

Manufacturer

Valeant Pharmacueticals International
  • Manufacturer Address
    Valeant Pharmacueticals International, 400 Somerset Corporate Blvd, Bridgewater NJ 08807-2867
  • Source
    USFDA