Cardinal Health is recalling 2.5 million of its Presource Procedure Packs with surgical gowns that may not be sterile.
The company recalled 9.1 million Level 3 surgical gowns last week that were produced by a contract manufacturer in locations not qualified by Cardinal Health to manufacture surgical gowns and where the environments were not controlled. Cardinal said it could not guarantee the sterility of the gowns and decided to recall them.
The company is now recalling the procedure packs containing the gowns. There are components in the packs that are not separated from the affected gown by inner, sealed packaging. The procedure packs were placed on hold earlier this month.
On Feb. 3, Cardinal Health will send customers detailed instructions for handling the affected procedure packs.
The company also is initiating a voluntary correction of 374,794 procedure packs, which had components separated from the gowns by inner, sealed packaging. The components that are separated by the packaging can be used, but any other components and the gown must be discarded.
"We understand the gravity of this situation and the disruptions to the healthcare system that will impact patient care," said Mike Kaufmann, CEO of Cardinal Health. "We are fully committed to making this right, and we are doing everything we can to ensure it never happens again."