Medical device manufacturer Cardinal Health will soon recall certain Level 3 surgical gowns or PreSource procedural packs that contain these gowns following warning that they may not be sterile, the U.S. Food and Drug Administration said in a statement.
The health regulator said it is working with the company to find out the specific product lots that are impacted, as well as to assess scope of potential contamination risk and possible supply chain disruptions or shortages.
Cardinal Health on January 11 and again on January 15 alerted its customers to potential quality issues affecting these gowns and the procedural packs. The company said it cannot guarantee that the products are sterile.
The company is communicating directly with its customers about the products directly impacted by the quality concern. The FDA said the company will be issuing a recall soon.
Surgical gowns that are commonly used during surgical procedures provide moderate to high risk barrier protection. The Level 3 gowns provide moderate risk protection. They are intended to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material.
The FDA said the issue may impact patient care at healthcare facilities, such as the cancellation of non-elective surgeries, but it is not aware of any patient harm because of the issue.-Nasdaq