Recall Z-2593-2014— CareFusion 203, Inc.

Name: FDA recall Z-2593-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-08

Class I · Terminated

Class I FDA medical device recall by CareFusion 203, Inc., initiated 2014-08-08, terminated 2015-10-07. It names one FDA 510(k) clearance: K070594. Product: CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is 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, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.. Reason: CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre.

Recalling firm: CareFusion 203, Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-08-08
Terminated: 2015-10-07
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 and ReVel Ventilators. The EnVe/ ReVel Ventilator is 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, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

Reason for recall

CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre

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