FDA-Device2015-08-26Class I
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
CareFusion 303, Inc.
Hazard
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
Sold states
Worldwide Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.
Affected count
68,460 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2015Don't want to check this manually?
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