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 AlarisÂ® 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 AlarisÂ® 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 handset from the patient prior to reprogramming the infusion pump.
“Implementation of the corrective action plan is an important area of focus for CareFusion and our customers, to ensure our medical devices in the field are operating as safely and effectively as possible,” said Dwight Winstead, chief operating officer of CareFusion. “We continue to work closely with the FDA under our new quality system with the goal of manufacturing and supporting products that are among the safest in the industry.”
The company recorded an $18 million reserve in its 2009 fiscal third quarter for all actions related to the corrective action plan and continues to believe the amount to be sufficient to fulfill its remediation obligations.
Instructions to customers
Customer inquiries related to this action should be addressed to the CareFusion recall center at 888-562-6018. Additional information about the recall can be found at www.cardinalhealth.com/alaris/medical-device-recall/.
CareFusion will work with customers to minimize disruption while correcting units at their facilities.
In the interim, customers should follow steps outlined in the June 12 Medical Device Recall Notification and the updated Notification for customers using the Alaris PCA module to minimize potential risk before implementation of the software and hardware updates.
CareFusion notified customers by registered letter on June 12, 2009, posted the customer letter on the company’s web site and set up a dedicated call center for customer support. The FDA has also been apprised of this action.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or at www.fda.gov/medwatch.
About CareFusion Corporation
CareFusion Corporation, a wholly owned subsidiary of Cardinal Health (NYSE:CAH), is expected to become a public company with the planned spinoff of the clinical and medical products businesses of Cardinal Health. The global company serves the health care industry with products and services that help hospitals measurably improve the safety and quality of healthcare. CareFusion develops market-leading technologies including AlarisÂ® IV pumps, PyxisÂ® automated dispensing and patient identification systems, AVEA and Pulmonetic Systemsâ„¢ ventilation and respiratory products, ChloraPrepÂ® for infection prevention and MedMinedâ„¢ services for infection surveillance, neurological monitoring and diagnostic products, V. MuellerÂ® surgical instruments and an extensive line of products that support interventional medicine.
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Manufactured in: Food Products – See Recall Description
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CareFusion employs more than 15,000 people across its global operations. The company has been authorized to have its shares of common stock listed on the New York Stock Exchange under the ticker symbol “CFN.” More information may be found at carefusion.com.