The Recall Desk
HighFDA (Devices)·Z-2362-2015·Announced 2015-08-26

CareFusion Alaris Syringe Pump Recall for Unresponsive Control Defect

CareFusion 303, Inc. is recalling Alaris Syringe Pumps, Model 8110, because they may become unresponsive to key presses after a channel error is cleared.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that delivers fluids, and the defect causes the device to become unresponsive to user input, which poses a risk of harm to patients even though no specific injuries are reported in the source text.

Plain-English summary

CareFusion 303, Inc. is recalling 68,460 units of the Alaris Syringe Pump, Model No. 8110. The recall involves specific BOM Housing Assembly Service and Lower Housing/Carriage Block Assembly parts. These devices are used to deliver fluids.

The recall is due to a defect where, after a channel error code is displayed and cleared on the PC unit, the syringe pump becomes unresponsive to key presses. The device remains unresponsive until the next power cycle or until the module is detached and reattached. The error is indicated by an audio and visual alarm on both the PC unit and the syringe module.

The affected units were distributed worldwide, including the United States, Australia, New Zealand, South Africa, Canada, the Middle East, Malaysia, and Taiwan. Users should check their device serial numbers against the provided list to determine if their unit is affected.

The recalled product

Product
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.
Affected units
68,460

Distribution

Distributed nationwide across the United States.