Cardinal Health is taking corrective actions related to the recall of 9.1 million surgical gowns, which could generate a company loss of $96 million in the second quarter, according to a Jan. 30 announcement.
Seven things to know:
1. In late January, Cardinal recalled AAMI level 3 surgical gowns in coordination with the FDA. About 2.9 million Presource Procedure Packs manufactured between September 2018 and January 2020 contained gowns included in the recall.
2. Cardinal voluntarily recalled more than 2.5 million procedure packs in which potentially contaminated gowns were not sealed off from other components. These should not be used and must be returned.
3. In 374,794 of the Presource kits, affected gowns were separated from other components by sealed inner packaging. Cardinal issued a voluntary correction for these packs, saying the separated components can still be used, but all others should be discarded.
4. Cardinal still has inventory of about 357,127 packs in which the affected gowns are not separated. Nearly 63,000 packs remaining in Cardinal's inventory have gowns separated from other components.
5. Cardinal customers will receive detailed instructions Feb. 3 on how to handle the affected procedure packs, which may contain a variety of customized components, including one or more gowns.
6. Cardinal's recall stems from the revelation that one of its FDA-authorized suppliers in China had shifted production of some gowns to unapproved sites in uncontrolled environments where sterility cannot be guaranteed.
7. Cardinal terminated its relationship with the supplier, Siyang HolyMed. Siyang HolyMed had outsourced productions to unqualified facilities before, in spring 2018.