More than 9 million surgical gowns recalled nationwide, some distributed to NC hospitals

A massive surgical gown recall has made ripples in the Triangle area.

Tuesday, Cardinal Health announced a voluntary recall of more than 9 million surgical gowns, 7.7 million of which had been sent to more than 2,800 health care facilities. According to a news release from Cardinal Health, the gowns were produced in unapproved locations that did not maintain standard environmental quality conditions, were not registered with the US Food and Drug Administration and were not qualified by Cardinal Health. The medical supplier said it could not guarantee that the products were sterile, and therefore the products should not be used.

The affected AAMI Level 3 surgical gowns had been produced since September 2018. According to the US Food and Drug Administration, surgical gowns protect both patients and health care workers from infectious agents, bodily fluids and dust during surgeries. Level 3 gowns are fairly common during surgical procedures like open heart surgery and knee replacements.

In a statement, the Food and Drug Administration said the recall could lead to the cancellation or delay of surgeries.

"There are very real consequences that medical device supply chain disruptions can have on patients, and we're committed to taking steps we can to mitigate any adverse patient impact. At this time, we are not aware of any patient harm because of this issue," the agency said in the written release.

University of North Carolina Health Care said it was affected by the recall, but that teams within the hospital worked quickly to find replacement supplies and minimize impact on patients.

"Our top priority is our patients' safety, and our team has made sure that none of the surgical kits are used at our hospitals. We will work closely with Cardinal and other vendors to ensure this situation is resolved," Alan Wolf, a spokesperson for UNC, said in an email.

Duke University Hospital said the recall did not impact patient care and no surgeries were cancelled or delayed.

"It did require our Supply Chain and Operations teams to identify clinically acceptable substitute items and ensure availability across the health system. We have been monitoring our supply chain on a daily basis with our partners to make sure that supply meets the demand in our health system," Duke officials said in an email.

The Food and Drug Administration said it is helping hospitals identify alternative approved medical suppliers that provide the same level of protection.
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