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# Don’t Use Certain Level 3 Surgical Gowns: Cardinal Health
- URL: https://www.fdaweb.com/dont-use-certain-level-3-surgical-gowns-cardinal-health/
- Published: 2020-01-16T12:00:00.000Z
- Updated: 2026-09-14T15:58:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145870

CDRH director **Jeffrey Shuren** says FDA agrees with a Cardinal Health recommendation that customers immediately discontinue using affected Level 3 surgical gowns and PreSource procedural packs containing the gowns because the manufacturer cannot provide assurance that the products are sterile. An FDA [notice](http://eyeonfda.com/2020/01/an-overview-of-fda-opdp-enforcement-for-2019/?ref=fdaweb.com) says the company alerted customers to potential quality issues affecting some of its Level 3 gowns on 1/11 and again on 1/15.

The notice says the agency is working closely with Cardinal Health to understand and address the quality issues with the products, including the potential risks to users and patients, which specific lots are affected, and the potential impact on the supply chain.

“At this time we are concerned about possible contamination of the products and agree with the manufacturer’s recommendation about not using the affected lots of Level 3 surgical gowns or PreSource procedural packs,” Shuren is quoted as saying. “We understand the company is continuing to communicate directly with its customers about which specific products are directly impacted by the quality concern and will be issuing a recall soon. We also understand that this issue may already be impacting patient care at healthcare facilities, such as the cancellation of non-elective surgeries. There are very real consequences that medical device supply chain disruptions can have on patients, and we’re committed to taking steps we can to mitigate any adverse patient impact. At this time we are not aware of any patient harm because of this issue.”