Z-0323-2018Class II

Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and...

Name: Z-0323-2018 Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and...
Creator: CareFusion 303, Inc.
Published: 2017-11-17
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2017-11-17 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of 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... on 2017-11-17. FDA classified it as Class II and gives the reason as "The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0323-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2018-01-08
Terminated: 2020-05-04
Recalling firm: CareFusion 303, Inc
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.
Product code: MEA Pump, Infusion, Pca
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued "Medical Device Safety Notification, dated November 17, 2017, via UPS. The letter describes the potential issue, affected products, potential risks, and required action for the users. The actions noted that clinicians can continue to use the device and follow the Alaris System User Manual for proper loading of the syringe. Per the manual, clinicians should ensure the plunger grippers lock and hold the syringe plunger in place. The Biomedical Engineering can detect if the device has this issue and if the issue described occurs, the user is to contact BD Support Center or email them to schedule service of the device at the BD Service Depot. Enclosed with the notification letter was a list of affected serial numbers, an excerpt from the user manual to "Prepare Syringe and Administration Set (Syringe Module)", and a customer response card to be returned via mail, email or FAX to confirm the notification has been received. For further questions, please call (858) 617-5977.
Quantity in commerce: 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, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwan, and South Africa.
Product codes and lots: UDI 10885403812002. Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0323-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0322-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-08
Z-0323-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-08

Product code MEA

K032233Class IIMedley Pca Module, Model 8120Alaris Medical Systems, Inc. / cleared 2003-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)