USA
On January 21, 2020, Cardinal Health informed customers of a voluntary recall for the surgical gowns produced by a contract manufacturer after discovering that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law, were not registered with the US Food and Drug Administration (FDA) and were not qualified by Cardinal Health.
Upon learning of the issue, Cardinal Health initiated an investigation, quarantined the gowns, placed a hold on distribution of the gowns and started communicating with customers to ensure that the affected gowns were removed from use.
A statement by the company reads: “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.
“Of the 9.1 million gowns included in this recall, 7.7 million units were distributed to 2,807 facilities. 1.4 million were produced but not distributed.
“To help address recall-related supply shortages, we have increased our own production of similar products and our employees have been working to identify alternative products. In many cases, we have been working with industry partners who offer competing products. We are also offering AAMI Level 4 Gowns to help bridge the supply gap.
“Since the product hold was announced, Cardinal Health has terminated its relationship with the contract manufacturer. As of early January, the contract manufacturer is no longer registered with the FDA.” The statement can be found here:
On the US Food and Drug Administration website, the FDA stated: “On January 11 and again on January 15, medical device manufacturer Cardinal Health, Dublin, Ohio, alerted its customers to potential quality issues affecting some of its Level 3 disposable surgical gowns and PreSource procedural packs that contain these gowns. Cardinal Health recommends, and FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the products are sterile.
"The FDA is working closely with Cardinal Health to understand and address the quality issues with these products, including the potential risks to users and patients, which specific product lots are impacted, and the potential impact on the supply chain.”
The full statement by the FDA on this issue can be found here:
