Tuesday, January 21, 2020 - Cardinal Health, based in Dublin, Ohio, has announced that it will issue a voluntary recall of Level 3 bulk non-sterile and single sterile surgical gowns and procedure packs after "cross contamination" at one of its manufacturing plants in China.
Cardinal Health issued a letter to its customers earlier this month to make them aware of their efforts to mitigate the problem. In it, company vice president Carl E. Hall and U.S. Category vice president Emily Gallo stated, "At this time, we cannot provide sterility assurances with respect to the gowns or the packs containing the gowns because of the potential for cross-contamination. Our communications with the FDA confirm our direction that the affected products and packs containing the affected products should not be used."
They continued, "We are advising customers to discontinue use and segregate all affected surgical gowns and procedure packs that include these affected surgical gowns from your current inventory."
According to the communication, Cardinal Health is now working with the FDA on the issue and is in the process of replacing gowns and packs in facilities with affected supplies.
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