Class 2 Device Recall CIVCO Biopsy Starter Kit

• Date Initiated by Firm: October 21, 2015
• Date Posted: November 17, 2015
• Recall Status: Terminated on February 28, 2017
• Recall Number: Z-0288-2016
• Recall Event ID: 72378
• 510(K)Number: K093713
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
• Code Information: M475840, M475850, M483080, M184760, M201120, M201220, M201230, M229890, M230450, M248410, M265470, M282270, M307490, M322230, M367370, M370090, M381360, M421260, M431550, M452150, M458370, M488300, M514070, M572510, M576810, M606320, M626250, M639290, M642350, M648020, M540640, M543800, M551990, M592190, M604120, M448100, M477600, M477700, M504340, M504350, M507520, M524270, M544100, M569330, M569340, M590710, M600460, M632390, M643140, M604180, M091360, M109060, M122250, M186540, M202260, M253050, M275630, M308820, M335740, M425050, M457560, M483250, M499390, M547370, M559550, M118570, M206960, M425030, M430820, M085360, M089740, M099100, M107610, M118700, M137600, M201810, M220800, M231940, M353380, M358810, M394960, M425020, M430810, M448670, M476410, M488580, M497660, M547740, M598410, M632210, M633570, M085370, M118680, M155510, M173420, M187860, M205340, M353390, M358170, M358580, M358590, M391700, M391710, M395610, M430800, M451470, M616810, M654380, M118610, M451460, M118650, M139440, M141830, M225010, M338400, M435250, M448680, M463740, M499630, M623350, M119380, M206950, M358560, M358570, M381520, M427660, M440600, M526290, M526300, M118660, M141820, M190870, M272570, M435240, M491500, M508640, M622060, M106080, M118600, M124610, M148440, M268900, M283940, M317630, M358610, M381510, M391680, M484430, M484440, M492320, M526260, M526270, M118710, M148450, M490000, M593130, M162020, M205920, M317680, M210700, M262520, M297390, M317690, M334110, M347120, M369110, M373250, M379350, M385180, M390160, M450210, M500620, M539310, M541330, M541830, M448110, M448120, M460670, M472720, M524230, M534750, M536730, M557450, M566960, M593280, M598060, M627710, M552010, M455790, M480870, M510000, M541140, M541810, M576640, M600450, M609740, M610550, M636940, M643130, M650780, M085390, M120660, M177390, M295660, M352830, M355940, M395670, M408960, M430430, M463720, M530670, M568980, M609970, M620480, M663970, M056500, M096880, M112390, M119730, M232970, M251160, M261840, M304420, M374360, M419670, M440460, M475460, M497670, M545750, M603800, M085550, M089260, M093020, M103030, M105150, M183050, M220960, M293580, M293590, M388690, M419650, M560740, M056760, M103040, M124110, M183060, M234590, M312170, M436670, M436680, M444740, M598550, M639430, M093010, M119280, M120400, M120860, M142690, M158480, M220970, M237740, M242000, M261770, M388700, M407620, M419660, M444950, M598860, M328300, M330340, M345110, M349600, M381530, M464980, M547940, M598070, M624410, M117130, M139400, M142090, M164840, M186690, M190180, M193400, M201660, M205110, M232930, M234630, M275650, M297260, M322700, M327850, M335060, M368160, M423720, M430440, M435750, M456910, M475140, M477930, M504290, M528270, M570840, M576930, M639440, M088430, M089650, M091400, M095990, M102210, M116290, M119930, M124320, M133350, M134540, M135520, M139740, M144670, M163200, M163260, M171240, M179410, M187920, M192750, M202990, M213370, M217330, M223270, M229780, M231960, M245390, M253360, M280960, M299320, M346870, M382670, M394080, M394090, M397380, M423700, M437090, M476650, M542430, M544290, M573360, and M618690
• Recalling Firm/ Manufacturer: Civco Medical Instruments Co. Inc.; 102 1st St S; Kalona IA 52247-9589
• For Additional Information Contact: James Leong; 319-248-6502
• Manufacturer Reason for Recall: Sterility of the product cannot be assured.
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 1139 boxes
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ITX