Cardinal Health has warned customers about potential quality issues with some of its surgical gowns and PreSource procedural packs that contain the gowns, and the company is recommending that customers immediately discontinue use of them.
An FDA notice says the agency is working closely with Cardinal Health to address the quality issues and pinpoint the cause of the issues. The FDA agrees with Cardinal's recommendation about not using the affected products.
The Level 3 gowns affected provide moderate risk protection and are used in several surgical procedures, such as open-heart surgery and knee replacements.
At this time, the FDA is not aware of any patient harm due to the quality issue.
Cardinal Health reached out to customers directly Jan. 11 and Jan. 15.