Recall Z-1791-2009 ยท FRN Pump, Infusion
Cardinal Health 303 dba Cardinal Health
The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). 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 | Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warning message on the user interface of the Alaris PC unit when used in conjunction with the Alaris PCA module. When the Alaris PC unit detects a programmed infusion for the Alaris PCA module that exceed |
| 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 | 186,000 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 |