Recall Z-2064-2016— CareFusion 303, Inc.
Class II · Terminated
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-05-12, terminated 2018-12-24. It names one FDA 510(k) clearance: K051641. Product: Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.. Reason: A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-12
- Terminated
- 2018-12-24
- 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 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Reason for recall
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
Data sourced from openFDA. This site is unofficial and independent of the FDA.