Cardinal Health surgical gowns, packs recalled
The voluntary recall of Level 3 surgical gowns and Presource procedural packs affecting human medical settings has widened to include possible distribution to veterinary hospitals, according to the FDA’s Center for Veterinary Medicine.
Surgical gowns and packs from a medical device manufacturer distributed to veterinary practices may not be sterile, according to an email dvm360 received yesterday from the U.S. Food and Drug Administration’s Center for Veterinary Medicine.
Customers of Level 3 surgical gowns and Presource procedural packs that contain these gowns should immediately discontinue their use, according to alerts from medical device manufacturer Cardinal Health. These items are used primarily in human medical facilities, but the FDA has now found that the items are in some veterinary settings as well.
“The FDA is working closely with Cardinal Health to understand and address the quality issues with these products, including the potential risks to users and patients, which specific product lots are impacted, and the potential impact on the supply chain,” according to a press release. “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.”
Customers with questions about whether their own inventory is affected should contact Cardinal Health directly.