CareFusion 303, Inc. recalls Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PC…

Recall date

November 17, 2017

Source

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

Recall number

Z-0322-2018

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution. There was also government and military distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahrain, Canada, Switzerland, United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiw…

Why it was recalled

The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.