Class 2 Device Recall Alaris PCA Module and Alaris PC Unit with software versions 8 thourh 9.1

• Date Initiated by Firm: March 04, 2009
• Date Posted: May 01, 2009
• Recall Status: Terminated on June 26, 2012
• Recall Number: Z-1237-2009
• Recall Event ID: 51432
• 510(K)Number: K032233 K012383
• Product Classification: Infusion Pump - Product Code FRN
• 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.
• Code Information: software versions 8 through 9.1. Serial Numbers: 000000000003692805, 000000000002326369 to 000000000012892953.
• Recalling Firm/ Manufacturer: Cardinal Health 303 dba Cardinal Health; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• For Additional Information Contact: 858-458-7000
• Manufacturer Reason for Recall: The Alaris PCA module can potentially infuse above or below the intended infusion dose.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.