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Analysis

Cardinal Health Plans Recall for Contaminated Surgical Gowns

By John Commins  
   January 20, 2020

The Dublin, Ohio-based medical supplier said took the action after learning of unsanitary 'environmental conditions' at a plant in China.

Cardinal Health is asking healthcare providers to stop using some types of surgical gowns and packs after learning of potential "cross contamination" at its manufacturing plant in China.

"We are advising customers to discontinue use and segregate all affected surgical gowns and procedure packs that include these affected surgical gowns from your current inventory," Cardinal Health said in a letter to customers this month.

"At this time, we cannot provide sterility assurances with respect to the gowns or the packs containing the gowns because of the potential for cross-contamination," Cardinal Health said. "The safety of our products is a responsibility we take very seriously. As such, we decided to issue the voluntary product hold."

The Dublin, Ohio-based medical supplier said took the action after learning of unsanitary "environmental conditions" at a plant in China that manufactures the supplier's AAMI Level 3 surgical gowns.

The notice affects certain lots of bulk non-sterile and single-sterile Cardinal Health™ surgical gowns.  

"We have initiated an investigation, placed a hold on potentially affected product inventory, and are working with the U.S. Food and Drug Administration to address this issue. Cardinal Health intends to initiate a product recall and will provide you with instructions soon," the letter stated.

“At this time, we cannot provide sterility assurances with respect to the gowns or the packs containing the gowns because of the potential for cross-contamination.”

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


KEY TAKEAWAYS

The notice affects certain lots of bulk non-sterile and single-sterile Cardinal Health™ surgical gowns.

Cardinal Health said it has notified the FDA, and intends to initiate a product recall.


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