Events

Retiro De Equipo (Recall) de VPRO 60

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Steris Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79101
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0772-2018
  • Fecha de publicación del evento
    2018-02-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161372
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Sterilizer, chemical - Product Code MLR
  • Causa
    Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
  • Acción
    The V-PRO 60 system software has been updated to ensure the VAPROX Sterilant expiration date is verified prior to the initiation of each sterilization cycle. STERIS Service Technicians will be contacting your facility to update your V-PRO 60 Sterilizer(s) with the revised system software. User Action  Users should continue to review their V-PRO 60 cycle printouts upon completion of each cycle to verify the VAPROX Sterilant was not expired. The VAPROX Sterilant expiration date is identified near the top of each cycle printout following all sterilization cycles as notated in the following illustration:

Device

VPRO 60
  • Modelo / Serial
    Serial numbers:  031591505 031611402 032941412 031831609 030261761 033161412 030991616 032641604 031451507 031621401 031691412 032941414 032861406 032941415 033141452 032861409 033161411 030231501 033241412 033241413 033241414 030231504 030231505 030231507 030231509 030231502 033151407 030341528 030441516 030231506 030231508 030341524 030341535 030361549 030361550 030501523 030501524 030501525 030681530 030681532 030341527 030681531 030341532 030341530 030441517 030341533 030441518 032861410 030341529 030501526 032941413 031191508 033181425 030341526 030441519 030441520 030501528 031191511 031271517 031191509 031191510 031341503 031341504 031271520 031271524 031351514 031451508 031351510 031351515 031411503 030341534 031411501 031411502 031451511 031451512 031271518 031591501 031591502 031591509 031591510 031591512 030361552 031451506 031541506 031451503 031541501 031541502 031541505 031541507 031541504 031591503 031591504 030681534 031351513 031591513 031631513 031631512 031631510 032111549 032181502 031631514 031771513 031831519 031771510 031771511 030361551 031701509 032281501 032361504 031771508 031771509 032361501 032401540 032401543 032221503 032221504 032281502 032361502 032361503 031271519 032281503 032281504 031831523 032181504 032401551 031951550 031951552 032401544 032471517 031951553 032681519 032611502 033161412 031271522 032541587 032181501 032611504 032611505 032681520 032681521 031631506 031831518 031831520 031771512 031701503 031591511 031631508 031841503 031841504 031631511 032611503 031951551 031901514 031701507 031901502 031901512 031771506 031631507 031701502 031831522 031841501 032751511 031701504 031701508 031771504 031901510 031951549 031841502 031841505 031901508 032061502 032061505 032061503 032061506 031701501 032111551 032111552 030121604 033521518 030121602 033451528 031451504 032681518 030221608 031541503 031771505 031771507 033521520 033521519 033521521 030221602 030351647 033521522 030141621 030141622 032061504 030221605 030291624 030351648 030421685 030421687 030291622 030351650 030221610 030291623 030291625 030561656 030221601 030491603 030491602 030611602 030351649 030421686 030561655 032181503 030631602 031701506 030781601 030831617 030831618 030921602 030781602 030921601 030921603 030831603 030921604 030991617 031111619 031051608 031111617 031051609 031111618 031191668 031191669 030351659 031951556 031481601 031261660 031481602 031481603 031481605 031191667 031331609 031621601 031621602 031621603 031621604 031691606 030221604 031051606 031751648 031831608 031901617 031551604 031691607 031831606 031831607 031831610 031831611 031961601 032111603 032041611 032071608 032251633 031551607 031581605 032071611 030221606 032321611 033341501 032111604 031901621 032071609 031961603 031961605 031901620 031961602 030221607 032321613 032391601 032391602 031961604 032521640 031901516 032111601 032221501 032491630 032561601 032631609 032631610 032251634 032461623 032491687 032491688 032641605 032521641 032671605 032801640 032881609 032881605 032321614 032981603 033071609 031691412 032671604 033001605 033021605 033051622 033171605 033051603 032111602 033091604 032671608 032671607 032671609 032741603 033171604 033171601 033301603 033091606 033301604 033331632 033441608 033441607 033471602 032741602 033511619 033091605 033171603 033611601 033611617 033611619 033651604 033611602 033611603 033611604 030091719 030301713 030301714 033611618 032671606 033651602 033611620 033441605 030021710 030341702 030481701 030581712 033651603 030021708 030021709 030021715 030441709 030481702 030511716 030581713 030091709 030091724 030091718 030101706 031271523 031591508 030621719 031901618 033441609 030111707 030121745 033231611 032981622 033471601 033511618 033511620 032911606 030131702 030261760 032521642 030301712 030341713 030551708 030551709 030481703 030551710 030551711 031141708 031141718 031461711 030121747 030441521 030261759 031261711 030131705 031221710 031291733 030201711 030231703 031811704 031881704 030511715 031911701 030091710 031881702 030121746 031881701 032251635 031881703 032191709
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Republic of Korea, Kuwait, Latvia, Malaysia, Mexico, Morocco, Myanmar, Panama, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and Vietnam.
  • Descripción del producto
    V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Dirección del fabricante
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Empresa matriz del fabricante (2017)
    Steris Corporation
  • Source
    USFDA