Cardinal Health begins recall of contaminated surgical gowns

By John Commins

Cardinal Health this week said it has launched "two voluntary field actions" for Cardinal Health Presource^® Procedure Packs containing gowns that were part of its recent recall of AAMI Level 3 surgical gowns.

Cardinal Health customers will receive detailed instructions for handling the affected procedure packs on February 3.

"I apologize to patients and our customers. We understand the gravity of this situation and the disruptions to the healthcare system that will impact patient care," Cardinal Health CEO Mike Kaufmann said in a media release. "We are fully committed to making this right, and we are doing everything we can to ensure it never happens again."

Cardinal Health said it expect to record a $96 million charge for the recall in the second quarter of Fiscal 2020, which the Dublin, Ohio-based medical supply company said is its "best estimate of costs for the recall, including inventory write-offs and other remediation costs, such as costs to replace recalled products."

The recall involves 2.9 million procedure packs manufactured between September 2018 and January 2020 that contain affected gowns, including:

• A voluntary correction of 374,794 procedure packs with components separated from the affected gown by inner, sealed packaging or other packs within the sterilization pouch.

  Cardinal said these packs can be "over-labeled," allowing the components within inner, sealed packages to be used after the gown is discarded. All other components including the gowns are to be removed and discarded. Approximately 62,976 of these packs remain in Cardinal's inventory.
   

• A voluntary recall of 2,518,653 procedure packs containing gowns with components that are not separated from the affected gown by inner, sealed packaging. Those procedure packs should not be used and must be returned. Approximately 357,127 of these packs remain with Cardinal.

Earlier this month, Cardinal asked healthcare providers to stop using some types of surgical gowns and packs after learning of potential "cross contamination" at the Siyang Holymed manufacturing plant in China. Cardinal said the gown maker had shifted production to sites with "uncontrolled enviromments" that were not approved by the U.S. Food and Drug Administration. Cardinal has since terminated its contract with Siyang Holymed.

To address shortages prompted by the recall, Cardinal Health is:

• Increasing its manufacturing production of similar and replacement products;
   
• Offering more protective AAMI Level 4 gowns to help bridge the supply gap;
   
• Working to identify alternatives – including in many cases working with industry partners who offer comparable products; and
   
• Mobilizing employees from all parts of the company to work directly with health care providers to replace gowns and procedure packs. 

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