Events

Recall of Device Recall Pulmonetic Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion 203, 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
    56201
  • Event Risk Class
    Class 2
  • Event Number
    Z-2205-2010
  • Event Initiated Date
    2010-07-02
  • Event Date Posted
    2010-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92962
  • 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
    ventilator, continuous, facility use - Product Code CBK
  • Reason
    Carefusion is recalling the p/n 19189-001 patient circuit (spu w/o peep 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. if the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both.
  • Action
    Customers were sent a CareFusion "Urgent Medical Device Recall Notification" dated July 2, 1010. The letter was addressed to Respiratory Care Manger. The letter described the product , problem and advised consignees to remove the affected product from inventory and promptly return it to CareFusion for replacement. Please contact CareFusion Technical Support at 800-754-1914, option 2, upon receipt of this notification to arrange for prompt return and replacement of any the patient circuits in your inventory.

Device

Device Recall Pulmonetic Systems
  • Model / Serial
    Y09D1922 Y09H0564 Y09H0565 Y09K0491 Y09K0492 Y09S1283 Y09S1284 Y10A1230
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AL, CA, FL, GA, HI, IL, IN, KS, MA,MI, MN, MT, NJ, NY, NC, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. || These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support.
  • Manufacturer
    CareFusion 203, Inc.

Manufacturer

CareFusion 203, Inc.
  • Manufacturer Address
    CareFusion 203, Inc., 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Manufacturer Parent Company (2017)
    Vyaire Holding Company
  • Source
    USFDA