Company: Cardinal Health
Date of Enforcement Report 8/26/2009
Class:l
PRODUCT
1) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above, Recall # Z-1790-2009;
2) 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, Recall # Z-1791-2009;
3) 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, Recall # Z-1792-2009;
4) Alaris Pump Module, Model 8100, Recall # Z-1793-2009;
5) Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patient-Controlled Analgesia (PCA), Model 8120; Alaris Syringe Module, Model 8110; Alaris SpO2 Module, Model 8210 and 8220 and Alaris EtCO2 Module, Model 8300, Recall # Z-1794-2009
REASON
There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, and may necessitate medical intervention to prevent serious injury and/or death.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health 303 dba Cardinal Health, San Diego, CA, by letters on June 12, 2009.
Manufacturer: Cardinal Health Manufacturing LLC, San Diego, CA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
500,000 units
DISTRIBUTION
Nationwide, Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand
