Recall Z-2006-2012— CareFusion 203, Inc.

Name: FDA recall Z-2006-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-19

Class I · Terminated

Class I FDA medical device recall by CareFusion 203, Inc., initiated 2012-06-19, terminated 2013-02-11. It names one FDA 510(k) clearance: K070594. Product: CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.. Reason: CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised..

Recalling firm: CareFusion 203, Inc.
Classification: Class I
Status: Terminated
Initiated: 2012-06-19
Terminated: 2013-02-11
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K070594 — PALMTOP VENTILATOR, MODELS PTV-8, PTV-10Pulmonetic Systems, Inc.·cleared 2007-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.

Reason for recall

CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.

Data sourced from openFDA. This site is unofficial and independent of the FDA.