Z-1793-2009

Alaris Pump Module, Model 8100

Name: Z-1793-2009 Alaris Pump Module, Model 8100
Creator: Cardinal Health 303 dba Cardinal Health
Published: 2009-06-12
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2009-06-12 / Terminated / root cause: design

FDA source

Cardinal Health 303 dba Cardinal Health began a recall of Alaris Pump Module, Model 8100 on 2009-06-12. The reason FDA records is "There is a potential risk of over infusion when certain fluids solidify in the pumping mechanism of the Alaris Pump module. This notification is to reinforce the importance of proper techniques for IV set loading and...". 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-1793-2009
Status: Terminated
Initiated: 2009-06-12
Posted: 2009-08-03
Terminated: 2012-03-19
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump Module, Model 8100.
Product code: FRN Pump, Infusion
Reason for recall: There is a potential risk of over infusion when certain fluids solidify in the pumping mechanism of the Alaris Pump module. This notification is to reinforce the importance of proper techniques for IV set loading and cleaning. When IV sets are improperly loaded, the set can tear and cause medication to leak and potentially enter the bezel area. Improper cleaning of the device, such as using hig
Root cause tag: design
FDA root cause: Device Design
Action: The recall was initiated on June 12, 2009 with the firm forwarding via UPS an Urgent: Medical Device Recall Notification with attached Customer Response Card to the Chief Administrative Officer, Director of Pharmacy, Director of Biomedical Engineering, Director of Nursing & Director of Risk Management of all of the affected consignees. Customers were also asked to please promptly complete and return the enclosed Customer Response Card to expedite the correction process. The Recall Notification informed the consignees of: (A) PROBLEM #1: Occlusion Warning Message for Alaris Pump Module; (B) PROBLEM #2 Syringe volume Warning Message for Alaris PCA module; (C) PROBLEM #3 Electrostatic Discharge (ESD) protection circuitry; (D) PROBLEM #4 Fluid Ingress and (E) PROBLEM #5 Alaris System Inter-Unit Interface (IUI) Connectors Labeling. The recall notice included "Required Action for Users & Follow-up actions by Cardinal Health for all five problems. Customers were also asked to report any adverse reactions experienced with the use of this product, and/or quality problems to the FDA's MedWatch Program. In addition, customer were provided the following contact information for the recall: (1) Cardinal Health Recall Center for general questions: By phone at 1-888-562-6018 7am to 5pm (Pacific) ; (2) Customer Advocacy for adverse reports: By phone at 1-800-854-7120, Option 1, Option 1, Option 3 or by email at [email protected] 24 hours a day, Sunday-Saturday; (3) Technical Support for Technical Questions regarding the Alaris System: By phone at 1-888-562-6018, 6am-5pm (Pacific). The firm followed-up with the release of a nationwide press statement regarding this issue on July 29, 2009. The press release indicated serial numbers of affected devices, as well as CareFusions short term instructions to customers, and the firms strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio
Quantity in commerce: 300,000 units
Distribution: Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.
Product codes and lots: Model 8100.

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)