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U.S. Department of Health and Human Services

Class 2 Device Recall Alaris PC Unit 8015

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 Class 2 Recall
Alaris PC Unit 8015
see related information
Date Posted April 15, 2013
Recall Status1 Terminated on May 08, 2014
Recall Number Z-1112-2013
Recall Event ID 64653
Premarket Notification
510(K) Number
K051641 
Product Classification Pump, Infusion - Product Code FRN
Product Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Code Information not available
Recalling Firm/
Manufacturer
Carefusion Corporation
3750 Torrey View Ct
San Diego, California 92130-2622
Manufacturer Reason
for Recall
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Carefusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are required to confirm receipt of the notification by returning the Recall response card to Carefusion by postage-paid, self-addressed mail, fax, or email. The letter stated that a Carefusion representatives will contact customers by telephone to schedule field remediation. For questions call Carefusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266, and/or Technical Support at 888-812-3229.
Quantity in Commerce 4,090 total units
Distribution Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
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