Recall Z-1792-2009 ยท FRN Pump, Infusion
Cardinal Health 303 dba Cardinal Health
The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules.
| Date | Aug 3, 2009 (initiated Jun 12, 2009) |
| Status | Terminated |
| Reason | There is a potential in the specified ESD (electrostatic discharge) protection circuitry in the keypad of Alaris PC units manufactured or serviced between April 2008 through January 2009. In these units there is a potential for the keypad not being responsive, key entries without key presses, or key entries that register incorrectly which may result in an over-infusion or under-infusion. An over |
| Root cause | Device Design |
| Action | The recall was initiated on June 12, 2009 with the firm forwarding via UPS an Urgent: Medical Device Recall Notification with attached Customer Response Card to the Chief Administrative Officer, Director of Pharmacy, Director of Biomedical Engineering, Director of Nursing & Director of Risk Management of all of the affected consignees. Customers were also asked to please promptly complete and return the enclosed Customer Response Card to expedite the correction process. The Recall Notification informed the consignees of: (A) PROBLEM #1: Occlusion Warning Message for Alaris Pump Module; (B) PR |
| Quantity | 30,000 units |
| Distribution | Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 Cardinal Health, Alaris Products, Oct 20, 2005 |