Alaris PCA Pump — Class II medical device recall Z-0323-2018
Terminated recall by CareFusion 303, Inc., reported 2018-01-17, distributed nationwide. The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper
| Recall number | Z-0323-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2017-11-17 |
| Classified | 2018-01-08 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2020-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BH, CA, CH, GB, KW, MX, MY, NL, NZ, QA, SA, TW, ZA |
| Quantity | 73,611 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10885403812002 |
| Model numbers | 8120 |
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 for recall
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0323-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.