Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Cranial Access Kit - Class 2 Recall

Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra ¿ Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium. This includes a hand drill with variable adjustable chuck; one or more drill bits with depth guards in pouches; twist lock drill guards for varying cranial drill bit depth settings. Those with Preparation Kits include Duraprep¿, saline solution, 1.5% Lidocaine, povidone-iodine solution, Betadine swabs and ointment for sterile entry site preparation. Procedural components and accessories like fenestrated drapes, towels, sponges, forceps, scissors, razors, scalpels, syringes, needles, sutures, hex wrenches, forceps, ruler and culture tubes. Each kit is packaged in preformed trays, double wrapped with CSR (Central Supply Room) wrap, placed in a single Tyvek/Polyethylene pouch and protective outer box. The contents of this portion of the kit are supplied sterile The Preparation kit included with some part numbers, is packaged separately and are added to the protective outer dispenser box after the product is returned from sterilization.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts