Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
Recall
- Recall Number
- Z-0455-2016
- Event Number
- 72632
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- CCK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 12, 2015
- Posted
- December 21, 2015
- Terminated
- January 23, 2017
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
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.
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 [email protected]. Customers with technical questions regarding the Alaris are instructed to contact Technical Support at (888) 812-3229 or by email at [email protected].
US Distribution.
157 units