Recall Z-0323-2018— CareFusion 303, Inc.

Name: FDA recall Z-0323-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-17

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2017-11-17, terminated 2020-05-04. It names one FDA 510(k) clearance: K032233. Product: Alaris PCA Pump, Model 8120. 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.. Reason: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Terminated: 2020-05-04
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K032233 — MEDLEY PCA MODULE, MODEL 8120Alaris Medical Systems, Inc.·cleared 2003-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alaris PCA Pump, Model 8120. 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.