Z-2205-2012Class I

Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent

Name: Z-2205-2012 Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent
Creator: CareFusion 303, Inc.
Published: 2012-06-15
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2012-06-15 / Terminated / root cause: design

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for... on 2012-06-15. FDA classified it as Class I and gives the reason as "The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2205-2012
Classification: Class I
Status: Terminated
Initiated: 2012-06-15
Posted: 2012-08-17
Terminated: 2014-05-13
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump Module Model 8100 (formerly Medley Pump Module) 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 has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
Root cause tag: design
FDA root cause: Device Design
Action: CareFusion sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 20, 2012. The letter identified the product, problem, and actions to be taken by the customers. The potential risk identified in the letter was that when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm. Termination of infusion could result in serious injury or death. Customers were informed that CareFusion will contact their facility with in 60 days of receiving the notification to schedule a visit to replace the door assembly of their affected pump module. Customers with recall related questions were instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports questions were instructed to contact Customer advocacy at (800) 854-7128, option 1, option 1, option 3 or e-mail at customer feedback @carefusion.com. Customers with technical questions were instructed to contact technical support at (888) 812-3229. Customers were instructed to promptly complete and return the enclosed Customer Response Card to expedite the corrective action process.
Quantity in commerce: 43,862 units total (40,780 units in the US)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
Product codes and lots: Model 8100; Lot/Serial numbers-various

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2205-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2205-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-17

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)