The Recall Desk

FDA (Devices) recall action 61943

Carefusion 2200 Inc recalled 3 products on 2012-07-11

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-07-11
Critical
0
Units
—

Why these products were recalled

The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2012-07-11

    CareFusion AirLife Infant Respiratory Circuits Recalled for Cracking Adapter

    CareFusion is recalling AirLife Isothermal Breathing Circuits because the Y adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-07-11

    CareFusion AirLife Infant Breathing Circuits Recalled for Cracking Adapter

    CareFusion is recalling AirLife infant breathing circuits because a Y adapter may crack, causing a leak that reduces air delivery to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilat
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2012-07-11

    CareFusion Infant Y Connector Recall Due to Spontaneous Cracking

    CareFusion is recalling AirLife Infant Patient Y Connectors because the adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator wh
    Category
    Distribution
    1 state