FDAFDA · Food and drugs·Recall number Z-2689-2014
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Published October 1, 2014 · Recall initiated: July 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion 2200 Inc
- Distributor
- Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT including Puerto Rico and the countries of Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland.
- Lot
- 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/CS , Product Code 10849-4S2 ; 14) CIRCUIT RESP INFANT 3FT HTD 30/CS , Product Code 10865-4H2 ; 15) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10868-4S2 ; 16) CIRCUIT RESP DISP INF HTD 30/CS , Product Code 1175-4H2 ; 17) CIRCUIT RESP INFANT DUAL DISP 30/CS , Product Code 1208-4H1 ; 18) CIRCUIT RESP INFANT DISP 30/CS , Product Code 1553-4H1 ; 19) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 1815-409 ; 20) CIRCUIT RESP INFANT 3FT HTD HI FI 30/CS , Product Code 1998-4H1 ; 21) INFANT RESP CIRC HTD 4 FT. , Product Code 2119-4S2G ; 22) INFANT RESP CIRC HTD 4 FT. , Product Code 2120-4S2G ; 23) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 4319-4H2 ; 24) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4326-4H2 ; 25) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4652-501 ; 26) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4677-4H2 ; 27) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4875-4H2 ; 28) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5665-4H2 ; 29) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 5682-409 ; 30) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5732-4H1 ; 31) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5868-4H2 ; 32) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6002-4H2 ; 33) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6040-501 ; 34) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 6074-4H1 ; 35) CIRCUIT RESP PED 7FT HTD 20/CS , Product Code 6274-H12 ; 36) CIRCUIT RESP PED 7FT HTD 20/CS , Product Code 6301-H12 ; 37) INFANT RESP CIRC HTD 4 FT , Product Code 6313-501 ; 38) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 6459-4H2 ; 39) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6485-4H2 ; 40) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 6588-4H2 ; 41) WYE KIT INFANT 30/CS , Product Code 6603-504 ; 42) CIRCUIT INFANT 6FT HTD INSP LINE 30/CS , Product Code 6862-504 ; 43) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6921-4H2 ; 44) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 6942-4H2 ; 45) CIRCUIT INFANT 4FT HTD 30/CS , Product Code 7100-4S2 ; 46) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7147-4S2 ; 47) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7156-4S2 ; 48) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7184-4S2 ; 49) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7206-4S2 ; 50) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 7213-4S2 ; 51) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7354-4S2 ; 52) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7395-4S2 ; 53) CIRCUIT RESP INFANT 4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.