Z-1112-2013 Class II Terminated
FDA device recall Z-1112-2013 was initiated by Carefusion Corporation on March 6, 2013 and is designated Class II. 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 parame… The recall status is terminated (terminated May 8, 2014). Affected quantity: 4,090 total units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- March 6, 2013
- Termination Date
- May 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,090 total units
Product Description
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
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
Distribution Pattern
Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
Code Information
not available