Cardinal Health has issued a voluntary recall of 9.1 surgical gowns amidst warnings of quality issues. The recall impacts Level 3 gowns and the Presource procedure packs that contain them. About 7.7 million units were distributed to more than 2800 facilities across the U.S.

"I apologize to patients and our customers. We understand the gravity of the situation and the disruption to the healthcare system that will impact patient care," says Mike Kaufman, CEO. "We are fully committed to making this right and we are doing everything we can to ensure it never happens again."

The gowns were made by a contract manufacturer at two locations that were neither registered with the FDA nor qualified by Cardinal Health to manufacture surgical gowns. A company investigator visited the locations and found several concerns including an open environment where gowns were exposed to air particulate and other contaminants.

The company is working with the FDA to resolve the issue. To minimize the impact of the recall, Cardinal has been increasing prodution of similar products and offering its Level 4 gowns instead. It is also working with competitors to bridge the supply gap.