Statement on quality issues with certain Cardinal Health surgical gowns and packs | FDA

Statement on quality issues with certain Cardinal Health surgical gowns and packs | FDA

Statement from Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health on quality issues with certain Cardinal Health surgical gowns and packs

FDA working with manufacturer to assess scope of potential contamination risk, possible supply chain disruptions

On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contains these gowns. Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the products are sterile. The FDA is working to assess the cause and full impact of these concerns. Surgical gowns are commonly used in health care facilities during surgical procedures and/or to provide moderate to high risk barrier protection. Gowns are classified into four levels of barrier protection based on their liquid barrier performance. Level 3 gowns provide moderate risk protection and are used in a wide-range of surgical procedures, such as open heart surgery and knee replacements. They are ...

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