Cardinal Health announces voluntary field actions for select procedure packs containing affected surgical gowns

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, we announced two voluntary field actions on approximately 2.9 million procedure packs containing potentially affected gowns.

The procedure pack field actions cover 2.9 million procedure packs containing the previously recalled gowns. Specifically: 

  • A voluntary recall of 374,794 surgical procedure packs with components separated from the affected gown by inner, sealed packaging or other packs within the sterilization pouch. These packs can be “over-labeled,” allowing components that are separated from the affected gown by inner, sealed packaging or other packs within the sterilization pouch to be used after the gown and any components that are not within inner, sealed packaging are discarded. 
  • A voluntary recall of 2,518,653 surgical procedure packs containing gowns with components that are not separated from the affected gown by sufficient inner, sealed packaging. Those packs should not be used and must be returned.

Cardinal Health is taking the following actions to address supply shortages as quickly as possible:

  • Increasing our manufacturing production of similar and replacement products;
  • Offering more protective AAMI Level 4 gowns to help bridge the supply gap;
  • Working to identify alternatives – including in many cases working with industry partners who offer comparable products; and
  • Mobilizing employees from all parts of our company to work directly with health care providers to replace gowns and procedure packs.

Moving forward, Cardinal Health is engaging 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 formed a special committee of the Board to oversee 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:

  • Hospitals – (800) 964-5227
  • Federal Government – (800) 444-1166
  • Distributors – (800) 635-6021
  • All Other Customers – (888) 444-5440

If providers are experiencing shortages, they should report surgical gown and procedure pack shortage issues to Cardinal Health and to the FDA at deviceshortages@fda.hhs.gov . 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.

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 and 15. 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 will experience limited backorders in the next few weeks. For procedure packs, we have already begun to send replenishment packs to customers, and this will continue to increase weekly. We are expediting delivery to include overnight shipping. Customers will start to feel more relief each week, and inventory levels on the packs will continue to increase. In the interim, Cardinal Health continues to supplement customers’ pack needs with substitutes or single sterile items.