A “voluntary product hold” and pending nationwide recall of surgical gowns distributed by Cardinal Health of Dublin, Ohio has affected Massachusetts hospitals.
Cardinal Health notified its customer base that certain of its AAMI Level 3 surgical gowns supplied to the company through a manufacturing facility could not be guaranteed as sterile due to potential cross-contamination problems. AAMI Level 3 is a designation by the Association for the Advancement of Medical Instrumentation and signifies a gown that provides moderate fluid barrier protection and is used for the widest range of surgical procedures. The company said it is working with the FDA to resolve the manufacturing issue. Some MHA member hospitals said they had begun searching for alternative suppliers.
The hold and recall specifically affects certain lots of bulk non-sterile and single-sterile Cardinal Health surgical gowns and Presource procedure packs that include the surgical gowns. The specific lot numbers were being transmitted to hospitals through the company’s sales reps.
“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,” Cardinal wrote, adding that it is ramping up production in non-affected facilities to cover potential product shortages.
The American Hospital Association, not the FDA, issued the notice about the Cardinal Health product hold. MHA in turn alerted the Massachusetts Department of Public Health.