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Integra LifeSciences Corp. d.b.a. Integra Pain Management recalls Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Recalled September 14, 2016 · FDA recall Z-2733-2016 · Integra LifeSciences Corp.
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. · FDA Class II
Units
710
Sold at
Nationwide and VA/govt/military. No foreign consignees.
Description
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.
Product
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Manufacturer(s)
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →