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 Federal Food, Drug and Cosmetic Act. The FDA may conduct its own inspection of CareFusion's infusion pump operations within 45 days. The company anticipates it will resume shipping its Alaris(R) 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. "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."
About CareFusion Corporation
CareFusion Corporation is currently a wholly owned subsidiary of Cardinal Health (NYSE:CAH) and is expected to become a public company from the planned spinoff of Cardinal Health's clinical and medical products businesses. The global company, with annual revenues of approximately $3.8 billion(1), will serve the health care industry with products and services that help hospitals improve the safety and quality of health care. With a focus on breaking the cycle of harmful medication errors and reducing hospital-acquired infections, CareFusion develops market-leading technologies including Alaris(R) IV pumps, Pyxis(R) automated dispensing and patient identification systems, MedMined(TM) electronic infection surveillance service, AVEA and Pulmonetic Systems ventilation and respiratory products, Jaeger and SensorMedics pulmonary products, ChloraPrep(R) infection prevention products and V. Mueller(R) surgical instruments. CareFusion employs more than 15,000 people across its global operations. The company has applied to have its shares of common stock listed on the New York Stock Exchange under the ticker symbol "CFN."
Source: PR Newswire
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