Cardinal Health Surgical Gowns May Not Be Sterile, FDA Warns

Megan Brooks


January 17, 2020

Healthcare facilities should immediately stop using Level 3 surgical gowns made by Cardinal Health and Presource procedural packs that contain these gowns because of concern over whether the gowns are sterile, the US Food and Drug Administration (FDA) and Cardinal Health advise.

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.

"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," Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement.

"The safety of our products is a responsibility that we take very seriously," Cardinal Health said in a statement sent to Medscape Medical News. "Upon becoming aware of an issue related to the environmental conditions at a contract manufacturer, we initiated an investigation, placed a voluntary hold on product inventory, and are working with the [FDA] to quickly resolve this issue for our customers and the patients they serve."

Cardinal Health has sent a letter to customers regarding this issue, stating that the company "intends to initiate a product recall and will provide you with instructions soon."

The FDA is not currently aware of any patients who have been harmed as a result of the issue, but "we are concerned about possible contamination of the products," Shuren said.

The problem has already led to cancellation of about a dozen surgeries in the Allegheny Health Network in western Pennsylvania, according to a report from news agency TRIBLIVE.

"There are very real consequences that medical device supply chain disruptions can have on patients, and we're committed to taking steps we can to mitigate any adverse patient impact," Shuren acknowledged. There are other FDA-cleared surgical gown alternatives on the market that provide Level 3 barrier protection, he noted.

The FDA is working with Cardinal Health to assess the cause of the potential sterility issues with the surgical gowns and will continue to monitor this "evolving" situation, Shuren said.

Healthcare facilities are encouraged to contact the FDA with information about potential or actual supply issues via a device shortages mailbox.

Customers with questions about this issue can contact Cardinal Health directly. 

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