FDA-Device2016-09-14Class II
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Integra LifeSciences Corp. d.b.a. Integra Pain Management
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.
Sold states
Nationwide and VA/govt/military. No foreign consignees.
Affected count
710
Manufactured in
3498 W 2400 S Ste 1050, Salt Lake City, UT, United States
Products
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2733-2016Don't want to check this manually?
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