[Recalled] Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. — Reports where the Low Battery alarm and/or the Very Low Battery alarm are not
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. |
|---|---|
| Brand / manufacturer | CareFusion 303, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1520-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 November 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from CareFusion 303, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.