Recall Z-2741-2020— CareFusion 303, Inc.
Class I · Terminated
Class I FDA medical device recall by CareFusion 303, Inc., initiated 2020-06-30, terminated 2024-04-22. It names one FDA 510(k) clearance: K133532. Product: Alaris System PC Unit Model 8015. modular infusion pump and monitoring system. Reason: If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-06-30
- Terminated
- 2024-04-22
- 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. modular infusion pump and monitoring system
Reason for recall
If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.