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FDA Warns Against Potentially Contaminated Surgical Gowns

Friday, January 17, 2020
This week, Cardinal Health – one of the leading manufacturers of surgical gowns in the country –  issued a statement that their Level 3 surgical gowns as well as the PreSource procedural packs that accompany them may not be sterile. The medical manufacturer and the FDA both recommend that healthcare providers discontinue use of these products.

“The FDA is working closely with Cardinal Health to understand and address the quality issues with these products, including the potential risks to users and patients, which specific product lots are impacted, and the potential impact on the supply chain. At this time, we are concerned about possible contamination of the products and agree with the manufacturer’s recommendation about not using the affected lots of Level 3 surgical gowns or PreSource procedural packs,” said Jeffrey E. Shuren, MD, JD, the director of the FDA’s CDRH office, in a statement.

Level 3 is the second highest level of protection for surgical gowns and offer protection for both the provider and patient by preventing the transfer of microorganisms, body fluids, and particulate material.  

Earlier this year, the American Society of Clinical Oncology presented a webinar reminding healthcare providers of the importance of personal protective equipment and safe handling of hazardous drugs such as chemotherapy.

With that in mind, nurses and other clinicians are encouraged to contact Cardinal Health directly if they have any questions or concerns, according to Shuren’s statement.

“We understand the company is continuing to communicate directly with its customers about which specific products are directly impacted by the quality concern and will be issuing a recall soon,” Shuren said.


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