Quality Issues with Certain Cardinal Health Surgical Gowns and Packs | FDA

Medical Gowns | FDA

Quality Issues with Certain Cardinal Health Surgical Gowns and Packs

Today, the U.S. Food and Drug Administration (FDA) is alerting the public about potential quality issues with some of Cardinal Health’s Level 3 surgical gowns and accompanying PreSource procedural packs. On January 11 and again on January 15, 2020, medical device manufacturer Cardinal Health alerted its customers. Cardinal Health recommends, and the FDA agrees, 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 closely with Cardinal Health to understand and address the quality issues with these products, including the potential risks to users and patients, which specific product lots are impacted, and the potential impact on the supply chain.

Read More Contact for Possible Gown Supply Issues or Shortages The FDA encourages health care facilities to email the FDA’s device shortages mailbox (deviceshortages@fda.hhs.gov) with information about potential or actual supply issues. Any user, patient, manufacturer, or organization within the supply chain that is aware of a delay in distribution of new product, or anticipates a potential or actual shortage, can notify us. If you have questions about this surgical gown quality issue, contact the Division of Industry and Consumer Education.