Cardinal Health to Recall Contaminated Disposable Gowns
On Jan. 11 and again on Jan. 15, medical device manufacturer Cardinal Health, Dublin, OH, alerted its customers to potential quality issues affecting some of its Level 3 disposable surgical gowns and PreSource procedural packs that contain these gowns. 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 U.S. Food & Drug Administration (FDA) is working to assess the cause and full impact of these concerns, according to a news release.
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, the FDA is concerned about possible contamination of the products and agrees with the manufacturer’s recommendation about not using the affected lots of Level 3 surgical gowns or PreSource procedural packs. Cardinal Health 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, according to the release.
Surgical gowns are commonly used in healthcare facilities during surgical procedures and/or to provide moderate to high-risk 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 healthcare personnel from transfer of microorganisms, body fluids and particulate material.
To read the full statement by the FDA on this issue, click here. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.