Recall Z-1901-2012— Carefusion 2200 Inc
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 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 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 recordK-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 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 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.