The Recall Desk

Manufacturer

CareFusion 203, Inc.

2 recalls in our database name CareFusion 203, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2014-10-01

Of the 2 recalls from CareFusion 203, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2593-2014·2014-10-01

    CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk

    CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.

    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 cont
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2012·2012-07-25

    CareFusion EnVe Ventilator Recalled for PEEP Pressure Control Failure

    CareFusion 203, Inc. is recalling 266 EnVe Ventilators because they may fail to hold set pressure values or alarm for circuit faults, potentially compromising patient ventilation.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide