FDAFDA · Alimentos y medicamentos·N.º oficial Z-0287-2016
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Publicado el 25 de noviembre de 2015 · Inicio del retiro: 21 de octubre de 2015
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Sterility of the product cannot be assured.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Civco Medical Instruments Co. Inc.
- Distribuidor
- Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.
- Lote
- M099850, M102860, M109690, M116920, M121840, M145200, M167240, M177420, M183850, M187880, M197330, M198000, M214900, M223090, M243020, M259940, M275080, M299890, M307610, M323480, M324340, M336880, M371260, M388610, M418830, M468260, M505290, M508000, M595790, M610020, M614660, M619370, M328280, M347150, M354390, M359630, M385190, M397110, M402790, M444170, M473920, M477540, M492030, M499400, M507160, M513450, M525040, M541820, M643750, M030030, M086380, M091280, M102870, M111660, M123680, M126080, M137910, M140300, M145210, M157840, M161840, M167250, M171090, M183020, M189070, M196210, M211180, M212890, M223100, M231440, M237620, M248310, M264360, M281640, M299900, M305420, M307400, M317480, M317770, M330280, M349060, M371270, M375160, M382480, M387010, M401610, M409400, M424530, M450070, M458240, M473700, M503560, M505300, M527200, M538410, M577750, M595800, M601380, M610780, M619380, M645840, M328290, M333440, M333900, M351980, M357390, M357430, M363450, M402800, M435210, M440470, M444240, M445560, M455870, M458780, M465230, M488220, M495560, M505790, M507610, M511470, M527370, M530970, M549930, M568660, M598380, M605200, M609520, M610190, M612150, M626760, M113980, M122090, M124190, M153630, M155540, M165430, M168960, M169740, M175890, M186700, M193520, M231410, M239510, M246180, M257780, M266760, M312790, M362170, M395860, M396870, M410330, M452260, M481510, M492020, M494620, M502320, M572970, M593290, M602160, M657490, M660000, M101260, M104980, M133950, M138380, M143100, M169200, M171950, M187800, M197320, M215100, M240270, M272370, M282240, M284870, M297910, M302490, M302680, M315550, M334520, M351870, M382620, M384290, M439310, M440000, M448600, M456880, M491590, M497000, M502440, M623240, M626430, M663670, M998920, M030040, M105680, M113440, M152150, M152940, M169210, M170230, M171840, M272150, M281840, M281950, M300120, M310780, M314090, M327470, M330010, M345300, M374880, M376770, M382630, M384280, M395870, M401010, M404110, M450390, M480400, M481490, M491580, M494340, M502340, M504250, M576110, M594750, M623230, M636250, M643670, M654360, M659160, M481500, M492040, M593520, M424160, and M472500
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States