Alaris Syringe Module Model 8110 with software version 9 — Class II medical device recall Z-2879-2016
Terminated recall by CareFusion 303, Inc., reported 2016-10-05, distributed nationwide. A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly
| Recall number | Z-2879-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2016-08-08 |
| Classified | 2016-09-23 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2018-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA |
| Quantity | 12,000 units |
| Reason classes | software |
| Model numbers | 8110 |
Product
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
Reason for recall
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
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-2879-2016. 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.