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CareFusion Issues Update Regarding Previously Disclosed June 12, 2009 Recall of the Alaris(R) System
Date:7/29/2009

SAN DIEGO, July 29 /PRNewswire/ -- CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following update regarding its previously disclosed recall of the Alaris System:

On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris(R) System addressing potential risks identified with the Alaris System. The affected devices have one or more failures associated with the Occlusion Warning Message, Syringe Volume Warning Message, Electrostatic Discharge protection circuitry, and Fluid Ingress into the device's pumping mechanism. This recall also updates the labeling for the Inter Unit Interface (IUI) connectors on the Alaris(R) System. The potential risks may lead to improper infusion therapy, which could cause serious adverse health consequences or death.

Serial numbers of affected devices, as well as CareFusion's short term instructions to customers, and the firm's strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/.

Following the FDA's 510(k) clearance of the firm's software correction in July 2009, CareFusion is now implementing corrections for units in the field.

In addition, CareFusion today began sending customers using the Alaris Patient Controlled Analgesia (PCA) module an update to the June 12, 2009, Medical Device Recall Notification. The update contains an additional required action to mitigate potential risk before completion of the field corrective action related to the Syringe Volume Warning Message that may appear while using the Alaris PC unit with the Alaris PCA module. The additional step involves removing the patient-controlled dose request h
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SOURCE CareFusion Corporation
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