Dive Brief:
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Cardinal Health is voluntarily recalling 9.1 million surgical gowns over a contract manufacturing issue that may have compromised their sterility, the company told customers Tuesday. Cardinal discovered that a contract manufacturer made the Class II medical devices at unapproved locations, leading it to quarantine the products and place a hold on distribution.
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It’s the latest step in Cardinal’s response to the issue, which it previously alerted customers to on both Jan. 11 and Jan. 15, prompting a statement from Center for Devices and Radiological Health Director Jeff Shuren last week saying the FDA is tracking impact of potential supply chain disruptions alongside the company.
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“We apologize for the hardship caused by the recall, and are doing everything we can to help resolve this issue for our customers and the patients they serve,” the company wrote in a statement.
Dive Insight:
Details of the quality problems and Cardinal’s response to them have trickled out in January. Cardinal told customers it learned of problems with environmental conditions at a site that makes gowns last week, leading to a voluntary product hold. At that stage, in a recommendation endorsed by FDA, Cardinal wanted customers to segregate and discontinue use of the affected surgical gowns.
“There are very real consequences that medical device supply chain disruptions can have on patients, and we’re committed to taking steps we can to mitigate any adverse patient impact,” Shuren said in FDA’s statement last week, adding that the agency was not aware of any patient harm related to the issue at that time.
This week, Cardinal went a step further, issuing an urgent medical device recall notice covering single-sterile and bulk non-sterile Non-Reinforced Surgical Gowns, Fabric-Reinforced Surgical Gowns and RoyalSilk Non-Reinforced Surgical Gowns made between September 2018 and January 2020.
Of the 9.1 million gowns covered by the recall, 7.7 million units have already been distributed. The gowns went to around 2,800 facilities, each of which will need to take action.
Pulling that many products from the market could affect the availability of gowns. Cardinal is aiming to mitigate the risk of disruption by increasing output of similar products, working with competitors to get their gowns to customers and providing gowns designed for use in higher-risk procedures.
The mitigating actions are needed in part because Cardinal cannot rely on the contract manufacturer at the root of the recall for support. Cardinal has stopped working with the company, which is no longer registered with FDA. The contract manufacturer is accused of making some gowns at sites that were neither registered with FDA nor qualified by Cardinal.
Some of the surgical gowns subject to the sterility concerns shipped as part of Cardinal’s Presource Kits, which feature multiple components needed to perform particular procedures. The kits are outside of the scope of the recall, although Cardinal plans to issue a separate field action focused on them later. For now, Cardinal is advising customers to stop using the affected surgical kits.
