A Medical Device Daily
CareFusion (San Diego), the company that will become public from the planned spinoff of Cardinal Health's (Dublin, Ohio) clinical and medical products businesses, filed a second amendment to its Form 10 registration statement with the Securities and Exchange Commission (SEC) that includes information about its post-spin board of directors and outlines progress being made to fulfill its obligations under a consent decree for its Alaris infusion products.
CareFusion also reported that the corrective action plan for field remediation of its infusion pumps, which the company submitted to the FDA in April as required by the amended consent decree, has been reviewed and found acceptable by the FDA. 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.
The company 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.
An additional requirement of the amended consent decree was completed on June 2, when 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 Food Drug and Cosmetic Act.