Alaris Pump model 8100 with software version 9 — Class I medical device recall Z-1567-2014
Terminated recall by CareFusion 303, Inc., reported 2014-05-21, distributed nationwide. CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that re
| Recall number | Z-1567-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2014-04-23 |
| Classified | 2014-05-14 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2017-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | software |
| Serial numbers | 12328622, 12356169, 12367206, 12367375, 12367447, 12367711, 12380280, 12383391, 12384026, 12384415, 12384476, 12387209, 12389266, 12389678, 12391019, 12391076, 12391102, 12391116, 12391165, 12391191, 12391192, 12391210, 12391218, 12391373, 12391629 and 475 more |
| Model numbers | 8100 |
Product
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
Reason for recall
CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1567-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.