January 21, 2020

FDA: Quality issues with Cardinal Health surgical gowns, packs

By: Judy Mathias

Editor's Note

The Food & Drug Administration (FDA) on January 16 announced that Cardinal Health has alerted it customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain the gowns.

Cardinal Health and the FDA recommend that customers immediately discontinue use of all affected gowns and packs that include these surgical gowns because the manufacturer cannot provide assurance that the products are sterile.

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The FDA is working to assess the cause and impact of these concerns. The issue may already be impacting patient care, such as cancellation of nonelective surgeries, the FDA says.


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