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CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circu...

FDA Device Recall #Z-2689-2014 — Class II — July 31, 2014

Recall Summary

Recall Number Z-2689-2014
Classification Class II — Moderate risk
Date Initiated July 31, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Carefusion 2200 Inc
Location Vernon Hills, IL
Product Type Devices
Quantity Approximately 318,280 devices

Product Description

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 for Recall

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.

Distribution Pattern

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 / Code Information

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 4FT HTD 30/CS , Product Code 7407-4S2 ; 54) CIRCUIT RESP INFANT 3FT HTD 30/CS , Product Code 7431-4S2 ; 55) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7441-4S2 ; 56) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7483-4S2 ; 57) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7526-4S2 ; 58) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 7575-4S2 ; 59) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 7582-4S2 ; 60) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7588-4S2 ; 61) INFANT INSP LINE HTD 30/CS , Product Code 775687-101 ; 62) INFANT INSP LINE HTD 30/CS , Product Code 775687-102 ; 63) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9052-4S2 ; 64) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9053-4S2 ; 65) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9054-4S2 ; 66) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 9055-4S2 ; 67) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9056-4S2 ; 68) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9058-4S2 ; 69) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC41-12010 ; 70) CIRCUIT RESP INFANT 40IN HTD 30/CS , Product Code RC41-12027 ; 71) CIRCUIT RESP INFANT 40IN HTD 30/CS , Product Code RC41-18039 ; 72) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC41-18052 ; 73) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC41-18060 ; 74) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code RC51-12002 ; 75) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code RC51-12074 ; 76) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC51-18004 ; 77) CIRCUIT NEONATE 4FT HTD W/ 30/CS , Product Code RT4851-00 ; 78) CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS , Product Code RT4851-12 ; 79) CIRCUIT NEO 4FT HTD W/18IN REMOTE 30/CS , Product Code RT4851-18

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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