FDA-Device2017-01-25Class I
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
CareFusion 303, Inc.
Hazard
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
Sold states
Nationwide Distribution
Affected count
382,635 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0950-2017Don't want to check this manually?
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