01/22/2020 | Press release | Archived content
The decision to recall certain AAMI Level 3 surgical gowns and some procedure packs was necessary based on information Cardinal Health received in December 2019 that Siyang HolyMed, one of our FDA-authorized suppliers in China, had shifted production of some gowns to unapproved sites, in uncontrolled environments. Because of this, Cardinal Health cannot assure sterility of the gowns, presenting a potential risk to patient safety. Cardinal Health has terminated our contract with Siyang HolyMed.
The January 21 voluntary recall covered three models of AAMI Level 3 surgical gowns (Non-Reinforced Surgical Gown, Fabric Reinforced Surgical Gown, and RoyalSilk Non-Reinforced Surgical Gown) manufactured between September 2018 and January 2020. Customers have been provided with specific lot numbers. This recall impacts approximately 9.1 million gowns manufactured by this supplier, approximately 7.7 million of which were distributed.
We issued field actions for procedure packs because some of those packs contain the previously recalled gowns. Presource® Procedure Packs can be standard or customized to a customer's specifications and can contain a variety of components, which may include one or more gowns. The procedure packs subject to the field actions have been on product hold since January 13, and on January 29 and February 25, we announced a total of three voluntary field actions on approximately 3 million procedure packs containing potentially affected gowns.
The procedure pack field actions cover approximately 3 million procedure packs containing the previously recalled gowns. Specifically:
Cardinal Health is taking the following actions to address supply shortages as quickly as possible:
Cardinal Health has engaged third-party experts to conduct a comprehensive review of quality assurance processes and business practices and committing to the execution of corrective and preventive actions. With management support, the Cardinal Health Board of Directors created a special committee of the Board that is overseeing management's actions in connection with the recall and related activities. The Committee is chaired by Director John Weiland, former vice chairman, president and chief operating officer of medical device company C.R. Bard, Inc.
Siyang HolyMed Products Co., Ltd. in Suqian Jiangsu, China.
No. Cardinal Health has terminated our contract with Siyang HolyMed.
Cardinal Health contacts for customer groups are:
If providers are experiencing shortages, they should report surgical gown and procedure pack shortage issues to Cardinal Health and to the FDA at [email protected]. We are working closely with the U.S. Food and Drug Administration ('FDA') to address this issue.
Cardinal Health customers received detailed instructions for handling the affected procedure packs on or about Saturday, February 1 and Wednesday, February, 26.
We stopped distributing the gowns on January 7, 2020, and contacted customers to inform them of the product hold for gowns and procedure packs on January 11, 13, 14, 15, 22, 29 and February 25. We provided the lot numbers of affected gowns and procedure packs and advised them to remove the gowns and procedure packs from use.
For single-sterile surgical gowns, we continue to experience backorders based on broader supply chain disruptions. We are focused on resolving this issue for our customers and the patients they serve.
For impacted Presource® procedure packs, we have been sending replenishment packs to customers for several weeks, and this will continue to increase weekly. We are expediting delivery to include overnight shipping. Customers should start to receive more product each week, and inventory levels on the packs should continue to increase. In the interim, we continue to supplement your pack needs with substitutes or single sterile items where available.
For more specific information, please contact your sales representative.
Samples of AAMI Level 3 gowns collected from the unregistered site (the same site that was the source of gowns that are the subject of the recall) were tested. On February 25, 2020, Cardinal Health informed customers that the testing showed that the microorganisms recovered and identified from the tested sample of gowns would not survive the sterilization process. While the test results support our prior assessment that the safety risk to customers and patients is low, there is no change to our field actions for the gowns and the Presource packs containing the gowns at this time.
Approximately 2.2 million gowns remain in our inventory from the voluntary recall, which was announced because the sterility of the gowns could not be assured for use in a surgical setting. We are donating those gowns to the Strategic National Stockpile operated by the Department of Health and Human Services, for their distribution as non-surgical isolation apparel, use that was authorized by HHS.