DUBLIN, OH – Cardinal Health’s CareFusion business is planning to announce a recall notification for certain Alaris infusion products.
Company officials announced Tuesday that a corrective action plan for field remediation of the infusion pumps, filed in April as part of a consent decree signed with the U.S. Food and Drug Administration in February 2007, has been accepted by the FDA. The company plans to issue a recall notification by June 12, and expects an $18 million reserve set aside in its fiscal third quarter will cover all costs.
The FDA had ordered amendments to the consent degree following a January 2008 inspection, in which it said certain infusion pumps did not satisfy the requirements of the Federal Food, Drug and Cosmetic Act. The company instituted a new quality system for the pumps on April 2, 2008 as part of the consent decree.
On June 2, an independent expert certified that the company’s infusion pump operations are in conformity with the Quality System Regulation and certain other provisions of the Federal Food, Drug and Cosmetic Act. The FDA may conduct its own inspection of CareFusion’s infusion pump operations within 45 days.
Company officials say they will resume shipping the Alaris PC unit and PCA module by the end of June, subject to 510(k) clearance from the FDA.
“We take our obligation to manufacture safe and effective products very seriously and have worked diligently to implement corrective actions and a new quality system for our infusion pump products,” said Dwight Winstead, chief operating officer of CareFusion, in a press release. “These important efforts will serve us well as we move forward as an independent company, helping to improve patient safety for hospitals around the world.”
Spin-off board
In related news, CareFusion has filed a second amendment to its form 10 registration with the U.S. Securities and Exchange Commission that includes, among other things, the makeup of its post-spinoff board of directors.
Named to the board are:
- David Schlotterbeck, 61, who will be the spinoff’s chairman and chief executive officer;
- Philip Francis, 61, chairman and chief executive officer of PetSmart, Inc. and a Cardinal Health director since 2006;
- Jacqueline Kosecoff, 59, chief executive officer of prescription solutions for the UnitedHealth Group;
- J. Michael Losh, 62, retired chief financial officer of General Motors and a Cardinal Health director since 1996;
- Gregory Lucier, 45, chairman and chief executive officer of Life Technologies;
- Edward Miller, MD, 66, chief executive officer of Johns Hopkins Medicine;
- Michael O’Halleran, 58, senior executive vice president of the Aon Corporation and a Cardinal Health director since 1999;
- and Robert Wayman, 63, retired executive vice president and chief financial officer of Hewlett Packard.
Francis, Losh and O’Halleran will leave the Cardinal Health board of directors upon completion of the planned spinoff.
“We are nearly complete with the selection process and believe the CareFusion board of directors will be a well balanced collection of executives with diverse backgrounds and experiences,” said Schlotterbeck. “With three directors transitioning to CareFusion from Cardinal Health and these four new directors, the board has the right mix to provide valuable historical perspective and fresh ideas to effectively oversee our businesses.”
CareFusion, which will contain Cardinal Health’s Clinical and medical products businesses, will be based in San Diego, is expected to employ 13,000 people and earn roughly $3.8 billion in annual revenue, and will include in its product line Alaris IV pumps, Pyxis automated dispensing systems, MedMined electronic infection surveillance services, AVEA respiratory care products and ChloraPrep skin preparation products.
