United States
On January 21, 2020, Cardinal Health informed customers of a voluntary recall of surgical gowns manufactured by a contract manufacturer after it was determined that some gowns were manufactured in unapproved locations where the required environmental conditions were not complied with by the US Food and Drug Administration (FDA) and have not been qualified by Cardinal Health.
When Cardinal Health found out about the problem, he initiated an investigation, isolated the gowns, stopped distributing the gowns, and began communicating with customers to ensure that the gowns concerned were no longer used.
A statement from the company states: “Based on the information available to us, we have determined that it is necessary to proactively set a blocking period for AAMI Level 3 surgical gowns that have been manufactured by a contract manufacturer since September 2018. These smocks are now subject to this voluntary recall.
“Of the 9.1 million clothes included in this recall, 7.7 million were distributed to 2,807 facilities. 1.4 million were produced but not distributed.
"To address recall-related delivery bottlenecks, we increased our own production of similar products and our employees worked to identify alternative products. In many cases, we have worked with industry partners who offer competing products. We also offer AAMI Level 4 gowns to fill the supply gap.
“Cardinal Health has ended the relationship with the contract manufacturer since the product stops were announced. From the beginning of January, the contract manufacturer is no longer registered with the FDA. “You can find the explanation here:
https://www.cardinalhealth.com/de/cmp/ext/corp/cardinal-health-surgical-gown-issue.html?cid=VURL-COR-MP-ORP-SURG-GownProdRecall-012120
The US Food and Drug Administration website states: “On January 11th and again on January 15th, medical device manufacturer Cardinal Health, Dublin, Ohio, alerted its customers to potential quality issues, including some of its disposable surgical gowns 3 and concern PreSource procedural packages with these clothes. Cardinal Health recommends and the FDA agrees that customers should immediately discontinue use of all affected surgical gowns and pre-source packs containing these surgical gowns as the manufacturer cannot guarantee the sterility of the products.
"The FDA works closely with Cardinal Health to understand and address the quality issues with these products, including the potential risks to users and patients that affect certain product batches and the potential impact on the supply chain."
The full FDA statement on this topic can be found here:
https://www.fda.gov/news-events/presse-ankündigungen/statement-quality-issues-certain-cardinal-health-surgical-gowns-and-packs
