Covidien, a leading global provider of healthcare products, has increased manufacturing of its made in the United States cotton-based wound care products to ensure there are no disruptions in the supply of these materials.
The Food and Drug Administration (FDA) recently announced an import alert on certain steam-sterilized plastic bandages and cotton pads that are imported from China. These products have been detained without physical examination due to microbiological contamination. Covidien does not import or distribute any of the steam-sterilized products that are impacted by the FDA’s decision.
Microbiological analysis by the FDA's Winchester Engineering and Analytical Center using the U.S.P. Sterility Test Method revealed that the detained plastic bandages and cotton pads were contaminated with various viable microorganisms. The FDA has indicated that the action to restrict importation of these products is due to the seriousness of the hazard posed by microbial contamination of sterile products.
The full import alert can be accessed HERE.
Covidien manufactures a full line of cotton-based wound care products in Augusta, Ga., where all products go through a stringent quality control process with continued monitoring to ensure quality and safety.
“Product safety is, and always will be, a priority at Covidien,” says Kristin Dietzler, vice president and general manager of nursing care at Covidien. “We continue to be a reliable partner, consistently delivering quality wound care products that meet the high standards of patients and caregivers alike. Covidien is proud to maintain manufacturing and sterilization for the vast majority of our wound care products the United States.”