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Recall Observatory FDA recall evidence

Device product

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.

Z-0287-2016

October 21, 2015

Class II

Product summary

Firm
Civco Medical Instruments Co. Inc.
Event
Event 72378
Status
Terminated
Classification
Class II
Quantity
508 boxes
Official record key
device-enforcement:Z-0287-2016

Official wording

Reason: Sterility of the product cannot be assured.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility of the product cannot be assured.