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.
This recall has been terminated (originally issued November 17, 2015).
- Recall Initiated
- October 21, 2015
- Posted
- November 17, 2015
- Terminated
- February 28, 2017
- Recall Number
- Z-0287-2016
- Quantity
- 508 boxes
- Firm Location
- Kalona, IA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility of the product cannot be assured.
Distribution
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.
Lot / Code Info
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
Root Cause
Process design
Action Taken
Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email order@civco.com. For questions regarding this recall call 319-248-6502.