Millions of surgical gowns made in China are being recalled because they may not be sterile. Surgeries are now being canceled in some hospitals.
Alan Levine, CEO of Ballad Health in Tennessee, said they had to reschedule 200 surgeries.
“We still don’t know if whether we’ve hit the worst of it or not,” Levine said.
On Thursday, Cardinal Health admitted that a Chinese contractor supplying its gowns was using factories not registered with the U.S. Food and Drug Administration. The company said these facilities did not “maintain proper environmental conditions.” Problems included gowns exposed to contaminants through open windows, failure to provide hand sanitation, and operators eating in the production area.
In 2018, Cardinal Health caught the same supplier using an unregistered factory. Back then, the company did testing and concluded there was “no impact to its products.” It did not tell the FDA.
The gowns are often included in a package, along with other surgical equipment. All of the objects inside the surgical pack are supposed to be sterile. But because they can’t guarantee that the gown is sterile, it could have contaminated other objects in the pack.
CBS News asked the FDA if it conducted any inspections of the unregistered subcontractors uncovered by Cardinal Health. The FDA declined to answer. Cardinal Health said it’s no longer working with that Chinese contractor and is cooperating with the FDA.
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