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Cardinal Health Recalls 9.1 Mln Surgical Gowns

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Medical device manufacturer Cardinal Health announced that it has recalled around 9.1 million surgical gowns for not being sterile. The recall involves AAMI Level 3 surgical gowns produced by a contract manufacturer since September 2018.

Cardinal Health said it has increased its own production of similar products to meet the recall-related supply shortages. The company is trying to identify alternative products, and is also working with industry partners for competing products. Further, AAMI Level 4 Gowns are also being offered to help bridge the supply gap.

The Dublin, Ohio-based company noted that the recall was initiated after discovering that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. They were also not registered with the U.S. Food and Drug Administration and were not qualified by Cardinal Health.

Cardinal Health said it initiated an investigation, quarantined the gowns, placed a hold on distribution of the gowns.

Of the 9.1 million gowns included in this recall, 7.7 million units were distributed to 2,807 facilities, while 1.4 million were produced but not distributed.

The company also noted that it has terminated its relationship with the contract manufacturer.

Cardinal Health on January 11 and again on January 15 alerted its customers to potential quality issues affecting certain Level 3 surgical gowns or PreSource procedural packs that contain these gowns.

Last week, the FDA informed about the upcoming recall by Cardinal Health, and that it was working with the company to find out the specific product lots that are impacted.

Surgical gowns that are commonly used during surgical procedures provide moderate to high risk barrier protection. The Level 3 gowns provide moderate risk protection.

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