FDA Device recall Z-1811-2015
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring an…
- FDA Device
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring an… by Carefusion 303, citing an issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1811-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-13 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Reason
An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
Identifiers
| code_info | 2000863 2000879 2000946 12473445 12473494 12473519 12473530 12473531 12473535 12473629 12473840 12473846 12…2000863 2000879 2000946 12473445 12473494 12473519 12473530 12473531 12473535 12473629 12473840 12473846 12494992 12495525 12496140 12496473 12496474 12496493 12496497 12496514 12496528 12496529 12496551 12496552 12496554 12496568 12496570 12496571 12496572 12496591 12496594 12496595 12505909 12519370 12540760 12577165 12578322 12578596 12578604 12578636 12578645 12578662 12578687 12578750 12578762 12578857 12578899 12579095 12579194 12579499 12579566 12579643 12579689 12581148 12584449 12625758 12625765 12625901 12625916 12625930 12625933 12628604 12630285 12630778 12634157 12634382 12634783 12635363 12635391 12635539 12635928 12636509 12636901 12636967 12636979 12636980 12636984 12636985 12637133 12637353 12637658 12637799 12637853 12637881 12637907 12639373 12639381 12639382 12639406 12639410 12639414 12639495 12639536 12639552 12639555 12639558 12639583 12639590 12639617 12639636 126 |
|---|
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-1811-2015%22
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