CHA News

Manufacturer Places Hold on Surgical Gowns, Plans Recall

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Cardinal Health has recently announced a hold on Level 3 surgical gowns, and Presource procedure packs containing the gowns, because it is unable to ensure their sterility. The company, which also said it intends to issue a recall, is working with the Food and Drug Administration (FDA) to resolve the issue, and directs customers to their sales representatives to obtain lot numbers of affected items.

According to Cardinal, the hold originated with a quality issue at a contract manufacturing facility and has affected 25-30% of its Level 3 gowns. The FDA is engaged to help mitigate supply chain disruption and identify alternate Level 3 gowns. CHA will keep member hospitals and health systems updated as more information about this issue becomes available.