Class 1 Device Recall ALARIS PC UNIT

• Date Initiated by Firm: June 12, 2009
• Date Posted: August 03, 2009
• Recall Status: Terminated on March 19, 2012
• Recall Number: Z-1791-2009
• Recall Event ID: 52119
• 510(K)Number: K012383 K051641
• Product Classification: Pump, infusion - Product Code FRN
• Product: The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules.
• Code Information: Model Numbers 8000 and 8015 software version 8 and above when used with the Alaris PCA Module (Model 8120).
• 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: Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warning message on the user interface of the Alaris PC unit when used in conjunction with the Alaris PCA module. When the Alaris PC unit detects a programmed infusion for the Alaris PCA module that exceed
• FDA Determined 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 customerfeedback@cardinalhealth.com 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: 186,000 units
• Distribution: Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.
• 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; 510(K)s with Product Code = FRN