Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
FDA Recall Z-0455-2016 · Posted 2015-12-21
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Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeCCK
Date Initiated2015-11-12
Date Terminated2017-01-23
Product Quantity157 units
Reason for Recall
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.
Firm 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 [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].
Root Cause
Other
Distribution Pattern
US Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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