Cardinal Health has issued a hold of some surgical gowns and procedure packs made in a Chinese facility over concerns about whether the gowns are sterile.
The Dublin-based drug wholesaler alerted its customers of the issue on Jan. 11 and Jan. 15, according to the U.S. Food and Drug Administration. Cardinal Health is expected to issue a recall on these products soon.
The hold affects Level 3 surgical gowns and PreSource procedural packs that contain these gowns, according to the FDA. Level 3 gowns are used in a variety of surgeries, from knee replacements to open heart surgeries. Essentially, Cardinal is unable to say if the products are sterile, according to a letter it sent to customers on Wednesday.
“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,” a Cardinal Health spokesperson said in an email on Friday.
Customers were told to stop using the surgical gowns and the procedural packs that include these gowns.
The Ohio Hospital Association was asked by Cardinal Health to help spread the message to hospitals, said John Palmer, the group’s spokesman.
Palmer said such recalls are pretty uncommon and that he hadn’t seen one in the eight years that he has worked at the hospital association.
“With that type of issue — there’s surgeries and other types of procedures going on — you’ve got to take extra precautions to make sure nothing impacts the patent,” Palmer said.
The FDA is currently working with Cardinal Health to address the possible risks to patients.
“At this time, we are concerned about possible contamination of the products,” the agency said in a news release.
The FDA is currently not aware of any harm to patients because of the gowns.
The hold, however, could be affecting patients at health care facilities, such as canceling non-elective surgeries, the FDA said in a news release.
“There are very real consequences that medical device supply chain disruptions can have on patients,” the FDA said in the release.
Dispatch reporter Max Filby contributed to this story.