Z-1237-2009

Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris...

Name: Z-1237-2009 Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris...
Creator: Cardinal Health 303 dba Cardinal Health
Published: 2009-03-04
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2009-03-04 / Terminated / root cause: software

FDA source

Cardinal Health 303 dba Cardinal Health began a recall of Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1 on 2009-03-04. The reason FDA records is "The Alaris PCA module can potentially infuse above or below the intended infusion dose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1237-2009
Status: Terminated
Initiated: 2009-03-04
Posted: 2009-05-01
Terminated: 2012-06-26
Recalling firm: CareFusion 303, Inc
Product: Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1.
Product code: FRN Pump, Infusion
Reason for recall: The Alaris PCA module can potentially infuse above or below the intended infusion dose.
Root cause tag: software
FDA root cause: Software design
Action: The field action was initiated on March 11, 2009 with Cardinal Health sending by registered return receipt mail a Safety Alert to all customers using the Alaris PC Unit with software versions 8 through 9.1, which encompasses the subset of those customers that use the Alaris PCA Module. The Safety Alert was addressed to the Directors of Nursing, Pharmacy, Risk Management, and Biomedical Engineering at each hospital facility. If a customer did not respond to the Safety Alert, then Cardinal Heath notified that customer by telephone to verify receipt of the Safety Alert. This Safety Alert Informed the customers about a potential risk, and required them to: (1) Determine whether you use version 8 through 9.1 of the Alaris PC Unit. (2) Forward this Safety Alert to all Data Set owners (3) To immediately identify the potential risks review enclosed FAQs and Instructions for Data Set Review. (4)Continue to follow the Institute for Safe Medication Practices (ISMP) and the Joint Commission recommendation for safe medication administration - two nurses checking to ensure that the correct prescription is being entered into the PCA pump when first ordered and when there are any changes in the prescription (paying close attention to dosing units and infusion modes). The customers were also instructed to call our Support Center at 1-888-562-6018 with any questions. An updated Customer Recall Notification was forwarded by registered return receipt mail by Cardinal Health on April 15,2009. This notice reinforced the information in the first notice in addition to informing the customers of the hazard of an over-infusion or under-infusion of medication. Also, customers were given instruction for reporting any adverse reactions experienced with the use of the affected product and/or quality problems via the FDA's MedWatch Program.
Quantity in commerce: Approximately 164,000 units
Distribution: Worldwide Distribution -- USA, Canada, Germany, Malaysia, and Singapore.
Product codes and lots: software versions 8 through 9.1. Serial Numbers: 000000000003692805, 000000000002326369 to 000000000012892953.

Product code FRN

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)