[Recalled] CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) — 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options progra… | FDA 2020-02-04
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) |
|---|---|
| Brand / manufacturer | CareFusion 303, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1359-2020 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 04 February 2020 |
| EAN / barcode | 10885403801518 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class I 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
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
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.