Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Reported: March 29, 2017 Initiated: November 1, 2016 #Z-1520-2017
Product Description
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Reason for Recall
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.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 613,800 total units (575,221 units in US)
- Distribution
- Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.. Recalled by CareFusion 303, Inc.. Units affected: 613,800 total units (575,221 units in US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1520-2017.
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