Recall Z-0950-2017— CareFusion 303, Inc.
Class I · Terminated
Class I FDA medical device recall by CareFusion 303, Inc., initiated 2016-12-02, terminated 2018-07-24. It names one FDA 510(k) clearance: K950419. Product: Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. Reason: During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-12-02
- Terminated
- 2018-07-24
- 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 Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural
Reason for recall
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
Data sourced from openFDA. This site is unofficial and independent of the FDA.