FDA Device recall Z-1360-2020
CareFusion Alaris Pump Module, Model 8100
- FDA Device
- Class I
- ongoing
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class I recall of CareFusion Alaris Pump Module, Model 8100 by Carefusion 303, citing 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery ala….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1360-2020 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2020-02-04 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
CareFusion Alaris Pump Module, Model 8100
Reason
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Identifiers
| code_info | Software versions 12.1.0, and 9.33 and prior |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1360-2020%22
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