Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional in
FDA device recall Z-0455-2016 · posted 2015-12-21 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- 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.
- Action taken
- 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 with technical questions regarding the Alaris are instructed to contact Technical Support at (888) 812-3229 or by email at DL-US-INF-TechSupport@carefusion.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 157 units
- Distribution
- US Distribution.
- Date initiated
- 2015-11-12
- Date posted
- 2015-12-21
- Date terminated
- 2017-01-23
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (K031741) | Alaris Medical Systems, Inc. | 2004-02-09 |