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Terminated

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

FDA Recall Z-1112-2013 · Posted 2013-04-15

Recall StatusTerminated
Product CodeFRN
Date Initiated2013-03-06
Date Terminated2014-05-08
Product Quantity4,090 total units

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution USA Nationwide and the countries of Australia and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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