Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe...

FDA Device Recall #Z-0322-2018 — Class II — November 17, 2017

Recall Summary

Recall Number Z-0322-2018
Classification Class II — Moderate risk
Date Initiated November 17, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CareFusion 303, Inc.
Location San Diego, CA
Product Type Devices
Quantity 73,611

Product Description

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.

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.

Distribution Pattern

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, Taiwan, and South Africa.

Lot / Code Information

UDI 10885403810015. Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.

Other Recalls from CareFusion 303, Inc.

Recall # Classification Product Date
Z-1645-2026 Class II BD Alaris" System with Guardrails" Suite MX wit... Feb 11, 2026
Z-1028-2026 Class II BD Pyxis ES Enterprise Server Catalog Numbers 1... Dec 3, 2025
Z-0962-2026 Class II BD Pyxis MedStation ES, REF: 323, BD Pyxis M... Nov 20, 2025
Z-1217-2026 Class II BD Alaris" Pump Module model 8100 UDI-DI code:... Nov 6, 2025
Z-0430-2026 Class I BD Alaris infusion Pump Module 8100, REF: 8100;... Oct 17, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.