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Cardinal Health recalls millions of surgical gowns due to sterility concerns

The gowns were not registered with the U.S. Food and Drug Administration and were not qualified by Cardinal Health.

Jeff Lagasse, Associate Editor

This week, Cardinal Health informed customers of a voluntary recall for more than 9.1 million surgical gowns produced by a contract manufacturer after discovering that some gowns were produced in unapproved locations that didn't maintain proper environmental conditions as required by law, the system said in a recall notice.

The gowns were not registered with the U.S. Food and Drug Administration and were not qualified by Cardinal Health.

WHAT'S THE IMPACT

Once the system was made aware of the issue, Cardinal Health initiated an investigation, quarantined the gowns, placed a hold on their distribution and started communicating with customers to ensure that the affected gowns were removed from use.

Based on the information the organization had, it determined it was necessary to issue a hold for AAMI Level 3 surgical gowns produced by a contract manufacturer since September 2018. Those gowns are now subject to the voluntary recall.

Of the 9.1 million gowns included in the recall, 7.7 million were distributed to 2,807 facilities. More than 1 million were produced but not distributed.

To help address recall-related supply shortages, Cardinal Health has increased its own production of similar products, and employees have been working to identify alternative products. In some cases the system has been working with industry partners which offer competing products. It's also offering AAMI Level 4 Gowns to help bridge the supply gap.

Since the product hold was announced, Cardinal Health has terminated its relationship with the contract manufacturer. As of early January, the contract manufacturer is no longer registered with the FDA.

The gowns were included in the organization's PreSource Kits, but the kits aren't part of the recall and Cardinal Health said they would be subject to a separate "field action" at a later time.

The gowns were designated as Level 3 gowns, meaning they offer moderate risk protection.

THE LARGER TREND

Mass recalls aren't the most common phenomenon in healthcare, but they've been known to happen. In 2017, the FDA issued a recall of St. Jude implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to premature battery depletion. Lawsuits included one from Humana to recoup payments it made for the devices.

Twitter: @JELagasse

Email the writer: jeff.lagasse@himssmedia.com