FDAAugust 24, 2016device
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciences corp d b a integra pain managementintegraintegra lifesciences
Recall history
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