Device 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.
Z-0288-2016
Product summary
- Event
- Event 72378
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1139 boxes
- Official record key
device-enforcement:Z-0288-2016
Official wording
Reason: Sterility of the product cannot be assured.
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
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
Sterility of the product cannot be assured.