Recall Z-1237-2009 ยท FRN Pump, Infusion
Cardinal Health 303 dba Cardinal Health
Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1.
| Date | May 1, 2009 (initiated Mar 4, 2009) |
| Status | Terminated |
| Reason | The Alaris PCA module can potentially infuse above or below the intended infusion dose. |
| Root cause | Software design |
| Action | The field action was initiated on March 11, 2009 with Cardinal Health sending by registered return receipt mail a Safety Alert to all customers using the Alaris PC Unit with software versions 8 through 9.1, which encompasses the subset of those customers that use the Alaris PCA Module. The Safety Alert was addressed to the Directors of Nursing, Pharmacy, Risk Management, and Biomedical Engineering at each hospital facility. If a customer did not respond to the Safety Alert, then Cardinal Heath notified that customer by telephone to verify receipt of the Safety Alert. This Safety Alert Informe |
| Quantity | Approximately 164,000 units |
| Distribution | Worldwide Distribution -- USA, Canada, Germany, Malaysia, and Singapore. |
| FDA record | Open on fda.gov |