The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also not registered with the FDA and were not qualified by Cardinal Health.
Once informed of the issue, Cardinal Health began an investigation and quarantined the affected gowns, eventually determining that it was necessary to issue a hold for the AAMI Level 3 surgical gowns produced by the contract manufacturer from September 2018 onward.
The recall includes 7.7 million gowns that were distributed to 2,807 facilities, while 1.4 million were produced but not distributed, the company noted. To help allay concerns over supply shortages due to the recall, Cardinal Health said it is increasing production of similar products as its employees work to seek alternatives. The company also said it is offering AAMI Level 4 gowns to help with the shortage.
The FDA announced earlier this week that it is working to assess quality issues surrounding surgical gowns and the PreSource procedural packs that contain them. In the meantime, the FDA is identifying alternative surgical gowns to keep clinical care operations working smoothly. The agency is not aware of any patient harm related to the gown issue.
After the recall was announced, Cardinal Health terminated its relationship with the contract manufacturer, which, as of earlier this month, is no longer registered with the FDA, according to Cardinal Health’s statement. The company did not identify the manufacturer.
“Our top priority is the safety of patients and healthcare workers,” Cardinal Health said in the statement. “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.”