Cardinal Health (Dublin, OH) announced it is initiating two voluntary field actions for select Cardinal Health Presource Procedure Packs containing gowns that were part of last week’s recall of AAMI Level 3 surgical gowns. These procedure packs, also known as kits, had been placed on voluntary hold at the time of the gown recall.
Cardinal Health is initiating actions involving 2.9 million procedure packs manufactured between September 2018 and January 2020 that contain affected gowns. The affected procedure packs were placed on hold earlier this month. The gowns in the procedure packs are a subset of the 9.1 million gowns recalled last week.
The decision to recall the packs was based on information Cardinal Health received in December that one of its FDA-authorized suppliers in China, Siyang Holymed, had shifted production of some gowns to unapproved sites, in uncontrolled environments and therefore could not ensure their sterility. Cardinal Health has since terminated its relationship with Siyang Holymed.
Learn more about the recall and what the steps Cardinal is taking to correct the issue here.