Skip to main content

Analysis

Cardinal Health Announces Recall for 9.1M Surgical Gowns

By John Commins  
   January 23, 2020

An investigation determined that some gowns made since September 2018 were produced in unapproved locations with unsanitary conditions.

Cardinal Health has announced a voluntary recall of 9.1 million surgical gowns that may have been contaminated at a contracted manufacturing plant in China.

Of the 9.1 million AAMI Level 3 gowns included in the recall, 7.7 million units were distributed to 2,807 facilities, and 1.4 million were not distributed, Cardinal Health said in a media release.

An investigation by the Dublin, Ohio-based medical supplier determined that some gowns were produced in unapproved locations with improper environmental conditions, were not registered with the U.S. Food and Drug Administration, and did not pass Cardinal Health standards.

"Based on the information we had, we determined it was necessary to proactively issue a hold for AAMI Level 3 surgical gowns produced by a contract manufacturer since September 2018. Those gowns are now subject to this voluntary recall," Cardinal Health said in a media release.

Cardinal Health quarantined the gowns, stopped distribution, and warned customers to remove the gowns from service. The medical supplier also terminated its contract with the gown manufacturer, which is no longer registered with the FDA.

"Our top priority is the safety of patients and healthcare workers. We apologize for the hardship caused by the recall, and are doing everything we can to help resolve this issue for our customers and the patients they serve," Cardinal Health said.

To address any supply shortages created by the recall, Cardinal Health said it would increase production of similar gowns, and would identify alternative products, including those made by "industry partners who offer competing products."   

“We apologize for the hardship caused by the recall, and are doing everything we can to help resolve this issue for our customers and the patients they serve.”

John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.


KEY TAKEAWAYS

Of the 9.1 million AAMI Level 3 gowns included in the recall, 7.7 million units were distributed to 2,807 facilities, and 1.4 million were not distributed.

Cardinal Health quarantined the gowns, stopped distribution, and warned customers to remove the gowns from service.

The medical supplier ended its contract with the gown manufacturer, which is no longer registered with the FDA.

To address supply shortages, Cardinal Health said it would increase production of similar gowns, and would identify alternative products, including those made by competitors.


Get the latest on healthcare leadership in your inbox.