REDDING, CALIFORNIA – As reported by krcrtv.com, Cardinal Health, a health services and products company, has issued a recall of approximately $9.1 million surgical gowns due to issues with quality.
Cardinal Health is a health services and products company that sells a variety of medical equipment and supplies, including surgical gowns. The company recently issued a recall of approximately $9.1 million surgical gowns that were produced by a contract manufacturer that was not registered with the United States Food and Drug Administration (FDA) nor qualified by Cardinal Health.
As such, Cardinal Health was unable to guarantee that the surgical gowns were sterile, deciding to recall the Level 3 gowns. Numerous surgical centers and hospitals in Redding, Chico, and Red Bluff, California, indicated that the recall did not directly impact them.
Cardinal Health states that the gowns subject to recall were distributed to surgical centers and hospitals between September 1, 2019, and January 10, 2020. Cardinal Health is working directly with the FDA to address the issue.
FDA Releases Statement on Quality Issues with Cardinal Health Surgical Gowns
On January 16, 2020, The FDA issued a press release on its website providing details of the Cardinal Health surgical gown recall. The statement indicates that the FDA is working with Cardinal Health to assess the scope of “potential contamination risk” and possible supply chain disruptions.
According to the press release, the contamination risk is an important issue, but the supply chain disruptions may pose more of a problem for surgical centers, hospitals, and patients than the contamination risk. As such, the FDA “is engaged in activities to mitigate supply chain disruption that would negatively impact clinical care operations, including identifying alternative Level 3 gowns.” Healthcare facilities impacted by the recall are encouraged to contact the FDA with questions or concerns about potential or actual supply issues.
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