Recall Z-0534-2014 ยท FRN Pump, Infusion
CareFusion 303, Inc.
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.
| Date | Dec 20, 2013 (initiated Dec 5, 2013) |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | 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 wit |
| Quantity | 4824 total units (4242 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia. |
| FDA record | Open on fda.gov |