Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monit
FDA device recall Z-1112-2013 · posted 2013-04-15 · Terminated
Recall details
- Recalling firm
- Carefusion Corporation
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 4,090 total units
- Distribution
- Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
- Date initiated
- 2013-03-06
- Date posted
- 2013-04-15
- Date terminated
- 2014-05-08
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALARIS SYSTEM PC UNIT, MODEL 8001 (K051641) | Cardinal Health, Alaris Products | 2005-10-20 |