Z-2185-2012Class I

Alaris Pump Module model 8100. Subsequent

Name: Z-2185-2012 Alaris Pump Module model 8100. Subsequent
Creator: CareFusion 303, Inc.
Published: 2012-06-29
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2012-06-29 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids... on 2012-06-29. FDA classified it as Class I and gives the reason as "The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with...". 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-2185-2012
Classification: Class I
Status: Terminated
Initiated: 2012-06-29
Posted: 2012-08-15
Terminated: 2015-08-26
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
Product code: FRN Pump, Infusion
Reason for recall: The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: CareFusion sent an Urgent Medical Device Recall Notification letter dated July 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required action for users instructed high risk patients undergoing infusions at high rates, consider having additional devices as back up. Clinicians should weigh the risk/benefit to the patients before continuing to use the device. Customers with recall related questions were instructed to contact Carefusion support center at (888) 562-6018. Customers with adverse event report questions were instructed to contact customer advocacy at (800) 854-7128, option 1, option 1, option 3 or email at [email protected]. Customers with technical questions regarding the Alaris system were instructed to contact Technical support at (888) 812-3229. For questions regarding this recall call 858-617-4000.
Quantity in commerce: 102,248 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.
Product codes and lots: All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2185-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2185-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-15

Product code FRN

K950419Class IIThe Imed Orion Infusion Pump and Administration SetsImed Corp. / cleared 1995-06-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)