FDA Device recall Z-0455-2016
Alaris EtCO2 Module, Model 8300
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Alaris EtCO2 Module, Model 8300 by Carefusion 303, citing 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 EtC….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0455-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-12 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | n/a |
Product
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
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.
Identifiers
| code_info | 9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 1…9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 12481239 12593721 12623833 12623957 12668253 12679872 12697242 12698542 12736367 12805782 12807757 12868325 12870021 12916518 12918611 12919079 12921157 13034011 13034375 13038124 13050300 13050648 13051034 13061112 13072829 13075412 13077962 13088823 13106029 13106030 13106138 13106140 13122164 13122401 13122402 13122936 13136786 13141565 13142603 13143660 13143809 13143889 13167255 13169672 13173261 13177210 13178248 13178389 13178391 13178512 13178968 13178969 13186760 13187737 13188106 13189792 13190670 13216601 13220274 13316434 13316444 13316453 13316473 13316496 13317481 13317552 13317553 13457448 13463929 13464899 13469917 13470004 13470021 13476713 13476912 13477643 13480785 13482441 13482518 13489475 13491251 13521218 13559325 13559686 13569291 13582129 13602388 13621652 13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0455-2016%22
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