Recall Z-2689-2014
Carefusion 2200 Inc · initiated July 31, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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.
FDA-determined cause: No Marketing Application
Action taken
CareFusion sent an URGENT: PRODUCT RECALL letters dated July 31, 2014 to all affected customers. The letters instructed customers to: 1) perform a 100% physical inventory to verify if any of the affected product codes are in stock; 2) complete and return the attached Recall Response Form within 15 days; 3) notify any customers/parties that the recalled products were distributed to of the recall; 4) distributors should have all their customers return the products and a completed Recall Response Form to the distributor for credit; and, 5) customers should destroy the recalled products according to their disposal procedure. If a customers procedure(s) does not allow for the destruction of the recalled products, the customers was advised to contact CareFusion AirLife Customer Support at 800-323-9088 (Monday - Friday, 8:00 AM - 5:00 PM CST) for product return options. Customers will receive credit for all destroyed products. Direct accounts with questions about this recall should contact CareFusion AirLife Customer Support at 800-323-9088 (Monday - Friday, 8:00 AM - 5:00 PM CST) for additional information.
Details
- Recall number
- Z-2689-2014
- Initiated
- July 31, 2014
- Posted by FDA
- September 23, 2014
- Terminated
- February 8, 2016
- Product code
- BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Quantity
- Approximately 318,280 devices
- Distribution
- 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.
- Recalling firm
- Carefusion 2200 Inc, Vernon Hills, IL