FDA Device recall Z-0323-2018
Alaris PCA Pump, Model 8120
- FDA Device
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Alaris PCA Pump, Model 8120 by Carefusion 303, citing the syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0323-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-17 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carefusion 303 |
| Distribution | US |
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.
Identifiers
| code_info | UDI 10885403812002. Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0323-2018%22
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