Recall Z-1900-2012— Carefusion 2200 Inc

Name: FDA recall Z-1900-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-29

Class I · Terminated

Class I FDA medical device recall by Carefusion 2200 Inc, initiated 2012-05-29, terminated 2016-01-22. It names one FDA 510(k) clearance: K915226. 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 ventilation is administered to a patient.. Reason: 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..

Recalling firm: Carefusion 2200 Inc
Classification: Class I
Status: Terminated
Initiated: 2012-05-29
Terminated: 2016-01-22
Firm location: McGaw Park, 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

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 ventilation is administered to a patient.

Reason for recall

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.

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