Reported Oct 1, 2014 · Terminated

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

Carefusion 2200 Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carefusion 2200 Inc · 75 N Fairway Dr · Vernon Hills, IL · 60061-1845

Is this the product you have?

  • CareFusion AirLife Heated
  • Infant Breathing Circuit Product UsageRespiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient
Lot codes and dates

79 of 79 products

Products covered by this recall
Model / numberProduct as published
10127-4H1CIRCUIT RESP INFANT 4FT HTD 30/CS
10331N-4S2CIRCUIT RESP INFANT 4FT 30/CS
10351-4H2CIRCUIT RESP INFANT 4FT HTD 30/CS
10387-4S2CIRCUIT RESP INFANT 4FT HTD 30/CS
10392-503CIRCUIT RESP INFANT PV HTD 5FT 30/CS
10485-4H2CIRCUIT RESP INFANT 5FT HTD 30/CS
10520-504CIRCUIT INFANT INSP LINE HTD 8FT 30/CS
10555-4S2CIRCUIT RESP INFANT 4FT HTD 30/CS
10680-504CIRCUIT INFANT INSP LINE HTD 5FT 30/CS
10706-4S2CIRCUIT RESP INFANT 4FT HTD 30/CS
10790-4S2CIRCUIT RESP INFANT 4FT HTD 30/CS
10814-4S2CIRCUIT RESP INFANT 4FT HTD 30/CS
10849-4S2CIRCUIT RESP INFANT 4FT HTD 30/CS
10865-4H2CIRCUIT RESP INFANT 3FT HTD 30/CS
10868-4S2CIRCUIT RESP INFANT 5FT HTD 30/CS
1175-4H2CIRCUIT RESP DISP INF HTD 30/CS
1208-4H1CIRCUIT RESP INFANT DUAL DISP 30/CS
1553-4H1CIRCUIT RESP INFANT DISP 30/CS
1815-409CIRCUIT RESP INFANT 4FT HTD 30/CS
1998-4H1CIRCUIT RESP INFANT 3FT HTD HI FI 30/CS
Amount recalled
Approximately 318,280 devices

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 8, 2016 · Data as of Sep 19, 5:25 PM UTC

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