FDA-Device2016-10-05Class II
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
CareFusion 303, Inc.
Hazard
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
Sold states
Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.
Affected count
12,000 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2879-2016Don't want to check this manually?
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