CareFusion, a San Diego-based spinoff of Cardinal Health, has appointed eight members to its board of directors. Additionally, the company has obtained FDA approval for a corrective action plan for its Alaris infusion pumps and plans to issue a recall.
New board members
Serving on the board of directors for CareFusion will be:
• David Schlotterbeck, chairman and CEO;
• Philip Francis, chairman and CEO of PetSmart, and Cardinal director since 2006;
• Jacqueline Kosecoff, CEO of Prescription Solutions for UnitedHealth Group;
• J. Michael Losh, retired chief financial officer of General Motors and Cardinal director since 1996;
• Gregory Lucier, chairman and CEO of Life Technologies;
• Edward Miller, MD, CEO of Johns Hopkins Medicine;
• Michael O'Halleran, senior executive vice president of Aon and Cardinal director since 1999; and
• Robert Wayman, retired executive vice president and chief financial officer of Hewlett Packard.
Francis, Losh and O'Halleran will leave the Cardinal board of directors upon completion of the planned spinoff, the Dublin, Ohio-based company said.
Alaris consent decree progress
CareFusion also announced that the FDA has reviewed and approved a corrective action plan for field remediation of its Alaris infusion pumps. The company expects to issue a recall notification by June 12 to inform customers who have products affected by the recall, including details on remediation plans.
In March, Cardinal put a shipping hold on patient-controlled modules for its customizable Alaris pump systems after discovering that the module allowed for under- or overdosing, reported Columbus Business First. Cardinal struck a consent decree with the FDA on prior recalls of an Alaris all-in-one pump that was found to have a sticky keypad. That decree was amended this year to include all Alaris products.
The company said it recorded an $18 million reserve in its 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."
The FDA may conduct its own inspection of CareFusion's infusion pump operations within 45 days. CareFusion said it anticipates it will resume shipping its Alaris PC unit and PCA module by the end of June, subject to 510(k) clearance from the FDA.