Recall Z-2689-2014— Carefusion 2200 Inc

Name: FDA recall Z-2689-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-31

Class II · Terminated

Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2014-07-31, terminated 2016-02-08. It names one FDA 510(k) clearance: K915226. Product: CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.. Reason: The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient..

Recalling firm: Carefusion 2200 Inc
Classification: Class II
Status: Terminated
Initiated: 2014-07-31
Terminated: 2016-02-08
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K915226 — ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUITBaxter Healthcare Corp·cleared 1993-01-12

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 AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

Reason for recall

The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.

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