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City Rockville / Washington / DC / / Company C Street NW. SA / General Medical Co. / Holland-Rantos Co. / Ethicon Inc. / / Country United States / / / Event Product Issues / Product Recall / / IndustryTerm subcutaneous port-catheter systems / facility protocols / implanted blood access device / device exit site / access device / device exit-site / Web site addresses / subcutaneous devices / classified preamendments devices / chemical tolerance testing / chemical tolerance / preamendments devices / blood access device / insertion site / similar technology / blood access devices / predicate device / subcutaneous portcatheter devices / subcutaneous implanted blood access devices / preamendments device / postamendments devices / subcutaneous port-catheter devices / implanted blood access devices / federal law / recommended site / port-catheter systems / printing / prescription device / sterilized device / / MedicalCondition arterial thrombosis / vascular access steal syndrome / infectious complications / sterility / potential allergic reactions / anaphylaxis / Cardiac arrhythmia / embolism / fatal thromboembolism / nerve injury / Infection / decreased thrombus / bloodstream infections / steal syndrome / air embolism / venous thrombosis / continued sterility / thrombus / increased infection / thrombosis / injuries / / MedicalTreatment dialysis / embolization / catheter / catheters / hemodialysis / cannula / / Organization Panel / office of Management and Budget / Contact Lens Manufacturers Association / Center for Devices and Radiological Health / Division of Dockets Management / FDA / Statutory Authority / Department of Health / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Department of State / Congress / Medical Devices Advisory Committee / office of Legal Affairs / Implanted Blood Access Devices AGENCY / / Person Daniel Klimow / Leslie Kux / Silver Spring / / / Position Assistant Commissioner for Policy / Secretary of State / Executive / Governor / Commissioner / / Product Accidental / device / / ProgrammingLanguage DC / / ProvinceOrState Maryland / / PublishedMedium Public Law / / Technology dialysis / pdf / http / facility protocols / / URL www.regulations.gov / www.fda.gov/downloads / http / SocialTag 
Federal Register / Vol. 79, No[removed]Friday, July 25, [removed]Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA–2012–N–0303]