Bulletin 20-1

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Cardinal Health Has Issued an Urgent Medical Device Recall

On January 11 and again on January 15, 2020, medical device manufacturer Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns and alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain these gowns. Cardinal Health recommends, and the FDA agrees, that tissue banks in possession of such items 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 affected gowns were distributed between September 1, 2018, and January 10, 2020. Gowns manufactured prior to 2018 are not affected by this recall.

We understand the company is continuing to communicate directly with its customers about which specific products are directly impacted by the quality concern. In this process, AATB institutional members have received letters from Cardinal Health providing a description of the issue, item codes and lot numbers as well as actions required and contact information of Cardinal Health Customer Service. Detailed information can be obtained here:

PDF: Cardinal Health announces voluntary recall for select surgical gowns 

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, and is engaged in activities to mitigate supply chain disruption that would negatively impact clinical operations, including identifying alternative Level 3 gowns. There are numerous FDA-cleared surgical gown alternatives on the market that provide Level 3 barrier protection. Tissue banks with questions about whether their own inventory is affected should contact Cardinal Health through their website: https://www.cardinalhealth.com/en/about-us/contact-us.html.

Tissue banks experiencing supply issues as a result of the recall may contact the FDA through the FDA’s device shortages mailbox (deviceshortages@fda.hhs.gov). This incident is an example of the importance of an effective surveillance system for monitoring product and/or equipment recalls or notices. Each tissue establishment should have policies and procedures in place designed to manage this type of incident and should apply due diligence internally.

The AATB continues to monitor the situation and will provide its accredited institutional members with any new information as it becomes available.