Cardinal Health issued a voluntary recall of 9.1 million surgical gowns, a company spokesperson confirmed to Becker's Hospital Review.
Cardinal Health warned customers about potential quality issues with the Level 3 gowns and the Presource procedure packs that contain them last week. About 7.7 million were distributed to 2,807 facilities across the country.
The gowns were produced by a contract manufacturer in 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. Hand sanitation also was not provided.
Cardinal could not ensure that the affected gowns were sterile and decided to recall them.
"We apologize for the hardship caused by the recall, and are doing everything we can to help resolve this issue for our customers and the patients they serve," the company said.
The company is working with the FDA to resolve the issue. It has also increased production of similar products and is offering Level 4 gowns to help bridge the supply gap.
The Association for the Advancement of Medical Instrumentation has established a classification system for protective apparel used in healthcare facilities. The system ranks apparel on a scale of Level 1 to Level 4, with Level 4 gowns being the most protective.