The Recall Desk
HighFDA (Devices)·Z-0322-2018·Announced 2018-01-17

CareFusion Recalls Alaris Syringe Pumps Due to Plunger Gripper Failure

CareFusion is recalling Alaris Syringe Pump Model 8110 units because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

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 with a mechanical defect that could lead to improper medication delivery. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling 73,611 Alaris Syringe Pump Model 8110 units. These infusion pump modules are used to deliver medication or fluids to adults, pediatrics, and neonates through intravenous, subcutaneous, or epidural routes. The devices were distributed nationwide in the United States, including to government and military facilities, as well as to various countries worldwide.

The recall was initiated because the syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. This mechanical failure could interfere with the proper administration of medication or fluids. The affected devices were manufactured or serviced between May 1, 2013, and April 30, 2017.

Healthcare facilities and users of these devices should stop using the affected Alaris Syringe Pump Model 8110 units and contact CareFusion 303, Inc. for instructions on how to proceed with the recall and replacement or repair of the equipment.

The recalled product

Product
Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe
Affected units
73,611

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →