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U.S. Department of Health and Human Services

Class 1 Device Recall ALARIS PC UNIT

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  Class 1 Device Recall ALARIS PC UNIT see related information
Date Initiated by Firm June 12, 2009
Date Posted August 03, 2009
Recall Status1 Terminated 3 on March 19, 2012
Recall Number Z-1790-2009
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) with software version 4 and above.
Code Information Model Numbers 8000 and 8015 with software version 4 and above.
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		 There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, an
FDA Determined
Cause 2		 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 and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.
510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
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