CareFusion 303, Inc. recalls Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part N…

Recall date

July 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2362-2015

FDA classification

Class I

Brand / firm

CareFusion 303, Inc.

Sold / distributed

Worldwide Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.