The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

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.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Syringe Pump
Hazard
Affected units
68,460

Distribution

Distributed nationwide across the United States.

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