FDA Announces Potential Lack of Sterility With Cardinal Health Level 3 Surgical Gowns

The U.S. Food and Drug Administration (FDA) has announced potential quality issues with some of Cardinal Health's Level 3 surgical gowns and their accompanying PreSource procedural packs, specifically lack of assurance that the products are sterile. The gowns are intended to be worn to protect both the patient and health care personnel from improper transfer of microorganisms, body fluids and particulate material, and are commonly used in health care facilities during procedures such as open heart surgery.

Both the FDA and Cardinal Health suggest customers should immediately discontinue use of all affected surgical gowns and accompanying PreSource procedural packs as they continue to investigate. As of Jan. 16, Cardinal Health has stated that it is "not aware of any patient harm because of this issue."

Read the full announcement.

Keywords: ACC Advocacy, United States Food and Drug Administration, Surgical Attire, Health Facilities

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