The U.S. Food & Drug Administration (FDA) is advising providers to discontinue use of certain Cardinal Health surgical gowns and PreSource procedural packs that include the surgical gowns because of possible contamination.
As an FDA statement notes, On January 11 and 15, Cardinal alerted customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource packs. In the letter, Cardinal Health stated, "We are advising customers to discontinue use and segregate all affected surgical gowns and procedure packs that include these affected surgical gowns from your current inventory."
Level 3 gowns provide moderate risk protection and are used in many surgical procedures, such as open-heart surgery and knee replacements. They are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
FDA's is advising customers to discontinue use of these products because "… the manufacturer cannot provide assurance the products are sterile."
A HealthLeaders report notes that Cardinal Health is planning to recall the items after learning of potential cross-contamination at its China manufacturing plant.
FDA states that customers with questions about whether their inventory is affected should contact Cardinal Health.