510(k) K915226 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
| Applicant | Baxter Healthcare Corp, Valencia CA, US |
| Decision | Substantially Equivalent, Jan 12, 1993 |
| Received | Nov 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2014 | Carefusion 2200 Inc CareFusion AirLife Heated Infant Breathing Circuit
Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. Terminated |
BZE | None listed |
| Jun 29, 2012 | Carefusion 2200 Inc AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico
Respirat Terminated |
BZE | None listed |
| Jun 29, 2012 | Carefusion 2200 Inc AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico
Resp Terminated |
BZE | None listed |
| Jun 29, 2012 | Carefusion 2200 Inc AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA Terminated |
BZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.