Cardinal Health Announces Voluntary Recall of Potentially Contaminated Surgical Gowns

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Cardinal Health announced on Jan. 30, 2020, that it had terminated business with Siyang Holymed in Suqian, China. This termination came after the supplier outsourced some of its surgical gowns to a non-qualified facility lacking proper quality control standards for sterility.

After Cardinal Health terminated its contract with Siyang Holymed, it led to a recall of nine million surgical gowns, with hospitals across the country in need of an emergency replacement of gowns, according to Mass Device

Siyang Holymed is an FDA-authorized supplier of gowns; however, it had outsourced production to an unapproved site in December 2019. CBS News said that it asked the FDA if it conducted any of the inspections of the unregistered subcontractors that led to Cardinal Health’s uncovering of information. As of CBS News’ publication date on Jan. 31, the FDA had declined to answer, according to the news organization.

In mid-January, Cardinal Health alerted hospitals of potential issues involving quality control in some of its surgical gowns. On Jan. 16, 2020, the FDA  issued a statement saying, “Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the products are sterile. The FDA is working to assess the cause and full impact of these concerns.”

In 2018, Cardinal Health had another issue with Siyang Holymed moving production to another non-registered factory. At the time, the company did additional testing and determined there was no impact on the products and failed to alert the FDA of the change, according to CBS 17 News

With this new violation, Cardinal Health is conducting two field actions with the FDA of Presource® Procedure Packs containing gowns that were part of the AAMI Level 3 surgical gown recall. It is also placing a voluntary hold on the procedure packs pending results.

Cardinal Health has additionally announced a series of actions to deal with the shortage. These actions include increasing production of similar or replacement products, offering more AAMI Level 4 gowns to fill demand, providing alternatives — in some cases working with industry partners that offer comparable products — and mobilizing employees to the field to facilitate faster replacement.

Cardinal Health also stated they plan to engage third-party experts to conduct quality assurance procedures and business practices. The company says its board of directors formed a special committee to oversee management’s actions in connection with the recall and related activities.

Regardless, patients, hospitals and other involved parties should take care and exercise caution when dealing with Chinese-made medical products. With less government oversight and companies misinterpreting complex FDA laws and supply chain issues, potential contamination or other errors can happen.

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