FDA Warns of Potential Contamination With Some Cardinal Health Surgical Gowns
The US Food and Drug Administration (FDA) on Thursday advised health care providers to stop using certain Cardinal Health Level 3 surgical gowns and PreSource procedural packs due to possible product contamination.“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,” said FDA’s Center for Devices and Radiological Health Director Jeff Shuren.
Shuren said that Cardinal Health already notified its customers to the potential issues on 11 and 15 January and is planning to issue a recall for the affected products soon.
Surgical gowns are rated based on the level of liquid barrier performance they provide from Level 1 (minimal risk) to Level 4 (high risk).
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,” and are worn to protect both patients and medical personnel from exposure to bodily fluids or microorganisms, according to FDA.
Shuren noted that the issue may already be causing disruption for health care providers, including cancellation of non-elective surgeries. “There are very real consequences that medical device supply chain disruptions can have on patients, and we’re committed to taking steps we can to mitigate any adverse patient impact,” he said.
Health care providers are instructed to contact Cardinal Health directly to determine if their inventory is affected, and FDA notes that there are multiple alternative Level 3 surgical gowns on the market.
FDA