The FDA announced that it is working to assess quality issues surrounding surgical gowns and the PreSource procedural packs that contain them, all produced by Cardinal Health (NYSE:CAH).
Both Dublin, Ohio–based Cardinal Health and the FDA agree that customers should immediately discontinue the use of all affected gowns and the packs that include them because the manufacturer can’t provide assurance that the products are sterile, according to a statement late last week from the agency.
The concern surrounding the gowns and packs center around possible contamination of the products. According to the FDA statement, the issue may already be impacting patient care at health facilities as there have been cancellations of non-elective surgeries amid potential shortages of the gowns. However, the FDA said it is not aware of any patient harm related to the issue.
Currently, the FDA is identifying alternative surgical gowns to keep clinical care operations working smoothly. The surgical gowns are designed to provide moderate risk protection in a wide range of surgical procedures.
“The safety of our products is a responsibility that we take very seriously,” a Cardinal Health spokesperson told MassDevice. “Upon becoming aware of an issue related to the environmental conditions at a contract manufacturer, we initiated an investigation, placed a voluntary hold on product inventory, and are working with the U.S. Food and Drug Administration to quickly resolve this issue for our customers and the patients they serve.”