FDA Devices recall · Reported January 17, 2018
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 ep
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
CareFusion 303, Inc. recalled Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syr… - a moderate-severity action.
Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syr… was recalled by CareFusion 303, Inc. in January 17, 2018. Reason: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the grippe…. Check the official notice for the remedy. Verify recall #Z-0323-2018 with the FDA Devices before acting.
The recall
CareFusion 303, Inc. issued this moderate-severity FDA Devices recall-The syringe plunger grippers may fail to automatically close around the syringe plunger press when the grippe….
- Moderate
- severity level
- 74K units
- affected scope
- Class II
- classification
- January 17, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0323-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0323-2018 |
| Date reported | January 17, 2018 |
| Date initiated | November 17, 2017 |
| Recalling firm | CareFusion 303, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 73,611 |
| Distribution | 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, Malay… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0323-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026