Events

Recall of Device Recall SPAG2 unit nebulizers

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
    77289
  • Event Risk Class
    Class 2
  • Event Number
    Z-0384-2018
  • Event Initiated Date
    2017-03-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155627
  • 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
    Spag-2 unit nebulizers from lot j0571670ra were tested at next breath for particle sizing under the validated method, nb-tm-261, in november 2016. the particle size specification set in nb-spec-039 for dv10, dv50, & dv90 are a mean value of no more than 3.0¿m, 5.5 ¿m, and 15¿m respectively. initial testing of the nebulizers yielded four units that delivered particle sizes that did not meet the specification (nb-spec-039). the out of specification (oos) nebulizers were cleaned per the approved spag-2 procedure, spe-000127228 rev 2, to remove any product residue and were then re-evaluated. secondary testing yielded that three of the four nebulizers still did not meet the particle size specification. it was concluded that the 3 nebulizers from spag-2 lot j0571670ra failed to meet (spe-000127228 rev 2) did not resolve the high droplet size distribution values observed.
  • Action
    On April 4, 2017 Valeant Pharmaceuticals North America distributed Medical Device Voluntary Product Recall and Acknowledgement Forms to their customers via USPS. Valeant Pharmaceuticals are directly contacting those customers who have been shipped affected SPAG-2 devices to arrange pick up and testing of the nebulizer component. Only half of the nebulizers will be picked-up for particle-size testing at each account to prevent shortages of VIRAZOLE, which can only be used with the SPAG-2 device. Nebulizers that pass testing will be cleaned and returned. Nebulizers that do not pass testing will be disposed, and new nebulizers will be distributed to facilities once they become available. Customers are encouraged to complete and return the Acknowledgement Form via email to: valeant3012@stericycle.com.

Device

Device Recall SPAG2 unit nebulizers
  • Model / Serial
    Lot Number J0571670RA*/Serial Number 337170600007; Lot Number J0571670R*/Serial Number 337170600007; Lot Number J0571670/Serial Number 337170600007; Lot Number L0197340/Serial Number 340150600003; Lot Number K1900650/Serial Number 340150600003.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide & Canada
  • Product Description
    Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole. || --- CDRH Classification Name: Nebulizer (Direct Patient Interface)
  • Manufacturer
    Valeant Pharmacueticals International

Manufacturer

Valeant Pharmacueticals International
  • Manufacturer Address
    Valeant Pharmacueticals International, 1400 Goodman St N, Rochester NY 14609-3547
  • Source
    USFDA