Recall Z-0455-2016 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CareFusion 303, Inc.
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
| Date | Dec 21, 2015 (initiated Nov 12, 2015) |
| Status | Terminated |
| Reason | CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2. |
| Root cause | Other |
| Action | CareFusion sent an Urgent: Medical Device Recall Notification Important letter dated November 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Alaris EtCO2 Module ( model 8300) is being recalled because it may have been tested during service using a higher than specified concentration of CO2 Customers with questions regarding clinical inquiries, product complaints or clinical troubleshooting are instructed to contact Customer Advocacy at (888) 812-3266 or email at customerfeedback@carefusion.com. Customers |
| Quantity | 157 units |
| Distribution | US Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 Alaris Medical Systems, Inc., Feb 9, 2004 |