Recalls / —
—#123822
Product
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K041241, K051641
- Affected lot / code info
- not available
Why it was recalled
CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.
Root cause (FDA determination)
Software design
Action the firm took
CareFusion sent an Urgent Medical Device Recall Notification letter dated December 5, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to contact CareFusion Customer Advocacy at (888) 812-3266, if they experienced a SYSTEM ERROR on the Alaris PC unit. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to complete and return the enclosed Customer Response Card to expedite the corrective action process. Customers with questions were instructed to contact CareFusion Support Center at 888-562-6018, or for Technical Support call 888-812-3229.
Recalling firm
- Firm
- CareFusion 303, Inc.
- Address
- 10020 Pacific Mesa Blvd, San Diego, California 92121-4386
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
Timeline
- Recall initiated
- 2013-12-05
- Posted by FDA
- 2013-12-20
- Terminated
- 2016-06-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #123822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.