Carefusion 2200 Inc: 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.

Agency Publication Date: June 29, 2012

Affected Products

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 is administered to a patient.

product codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-5014677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12 and RT4851-18; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Lot Numbers:

numbers

0000414257

numbers

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.

product codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Lot Numbers:

numbers

0000414257

numbers

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.

product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Lot Numbers:

numbers

0000414257

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61943

Status: Resolved

Manufacturer: Carefusion 2200 Inc

Manufactured In: United States

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers:

numbers

0000414257

numbers

Lot Numbers:

numbers

0000414257

numbers

product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Lot Numbers:

numbers

0000414257

numbers