Recall Z-1520-2017— CareFusion 303, Inc.
Class II · Terminated
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-11-01, terminated 2020-04-24. It names one FDA 510(k) clearance: K051641. Product: Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.. Reason: 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..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-01
- Terminated
- 2020-04-24
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.