FDA Device recall Z-2689-2014

CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical…

FDA Device
Class II
terminated
Published 2014-10-01

On 2014-10-01 the FDA classified a Class II recall of CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical… by Carefusion 2200, citing 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 potent….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2689-2014
Classification	Class II
Status	terminated
Initiated	2014-07-31
Published	2014-10-01
Last updated	2026-09-13 11:53 UTC
Company	Carefusion 2200
Distribution	US

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.

Identifiers

code_info	All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2)… All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2) CIRCUIT RESP INFANT 4FT 30/CS , Product Code 10331N-4S2 ; 3) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10351-4H2 ; 4) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10387-4S2 ; 5) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 10392-503 ; 6) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10485-4H2 ; 7) CIRCUIT INFANT INSP LINE HTD 8FT 30/CS , Product Code 10520-504 ; 8) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10555-4S2 ; 9) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code 10680-504 ; 10) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10706-4S2 ; 11) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10790-4S2 ; 12) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10814-4S2 ; 13) CIRCUIT RESP INFANT 4FT HTD 30/

code_info

All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2)…

All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2) CIRCUIT RESP INFANT 4FT 30/CS , Product Code 10331N-4S2 ; 3) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10351-4H2 ; 4) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10387-4S2 ; 5) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 10392-503 ; 6) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10485-4H2 ; 7) CIRCUIT INFANT INSP LINE HTD 8FT 30/CS , Product Code 10520-504 ; 8) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10555-4S2 ; 9) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code 10680-504 ; 10) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10706-4S2 ; 11) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10790-4S2 ; 12) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10814-4S2 ; 13) CIRCUIT RESP INFANT 4FT HTD 30/

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2689-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.