On January 21, 2020, “Cardinal Health informed customers of a voluntary recall for the surgical gowns produced by a contract manufacturer after discovering that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law, were not registered with the U.S. Food and Drug Administration (FDA) and were not qualified by Cardinal Health.”
The recall involves AAMI Level 3 surgical gowns produced by a contract manufacturer since September 2018. 1.4 million of the 9.1 million gowns included in the voluntary recall were produced but not distributed. 7.7 million of the recalled surgical gowns were distributed to 2,807 facilities.
Since the voluntary recall was announced, Cardinal Health has terminated its relationship with the contract manufacturer and, as of early January 2020, the contract manufacturer is no longer registered with the FDA.
AAMI Level 3 surgical gowns protect both patients and health care workers from infectious agents, bodily fluids and dust during surgeries. Level 3 gowns are fairly common during surgical procedures like open heart surgery and knee replacements. The AAMI (Association for the Advancement of Medical Instrumentation) is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.
The FDA states on its website: “Surgical gowns are commonly used in health care facilities during surgical procedures and/or to provide moderate to high barrier protection. Gowns are classified into four levels of barrier protection based on their liquid barrier performance. Level 3 gowns provide moderate risk protection and are used in a wide-range of surgical procedures, such as open heart surgery and knee replacements. They are intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids, and particulate material.”
“FDA also understands this issue may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries. There are very real consequences that medical device supply chain disruptions can have on patients, and FDA is committed to taking what steps we can to mitigate any adverse patient impact. At this time, FDA is not aware of any patient harm because of this issue.”
The FDA recommends, “Customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include the surgical gowns because the manufacturer cannot provide assurance the products are sterile.”
Cardinal Health states on its website: “Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home.”
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