Events

Retiro De Equipo (Recall) de STERRAD Cyclesure

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 Advanced Sterilization Products.

¿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
    64972
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1180-2013
  • Fecha de inicio del evento
    2013-04-22
  • Fecha de publicación del evento
    2013-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117569
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Causa
    Advanced sterilization products is recalling certain lots of sterrad cyclesure 24 biological indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.
  • Acción
    Advanced Sterilization Products sent an Urgent Medical Device Recall letter dated April 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that have installed and validated STERRAD system between Feb 2012 and March 2013, are instructed to contact Stericycle at (888) 943-4901 to determine if their STERRAD System is eligible for an optional revalidation. If customers would like to have their system validation repeated, ASP will revalidate their system without charge. Customers are instructed that the revalidation can occur as part of a routine Planned Maintenance (PM) within 12 months. Customers are also notified that the optional procedure will require that their Sterrad System will be unavailable for use for approximately 31 hours (depending on their system) while revalidation is performed. Customers are instructed to contact Stericycle at the number above with their STERRAD System serial number by May 31 2013. Customers are instructed to contact Stericycle at (888) 943-4898 or contact their ASP representative. Stericycle's hours of operations are Mon-Fri , 8am-5pm, ET.

Device

STERRAD Cyclesure
  • Modelo / Serial
    Lot Codes:  025127 026127 027127 028127 030127 031127 032127 033127 034127 035127 036127 037127 038121 038127 039127 040127 041121 042127 043127 044127 045121 046127 047127 048127 049127 052127 053121 053127 054127 055121 056127 057127 058127 059127 060127 061127 062121 062127 063127 064127 065127 067127 068127 069121 070127 071127 072127 073127 076121 081127 082127 084127 085127 086121 086127 087127 089127 090127 091127 092127 093121 094127 095127 100121 100127 101127 102127 104127 107121 107127 107128 109127 109128 110127 111127 114121 118127 121121 121127 122127 123127 124127 125127 128121 128127 129127 130127 131127 132127 135121 135127 136127 137127 156121 156127 158127 159127 160127 163121 163127 164127 165127 13912706 18112706 18412706 18512706 18712706 18812706 19012706 19212706 19312706 19412706 19512706 19712706 19812106 19912706 20012106 20112706 20212706 20512106 20512706 20612106 20612706 20712706 20812106 20812706 21212106 21212706 21312106 21312706 21412706 21512106 21512806 21612106 21812706 21912706 22012106 22112706 22212706 22312706 22612106 22612706 22712706 22812106 22812706 22912706 23012106 23012706 23112706 23312106 23312706 23412706 23512106 23512706 23612706 23712106 23712706 23812706 24012106 24012706 24112706 24212106 24212706 24312706 24412706 24812106 24812706 24912106 24912706 25012706 25112706 25412106 25412706 25512106 25512706 25612106 25812106 25812706 25912706 26112106 26212706 26312106 26312706 26812106 26812706 30112706
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN.
  • Descripción del producto
    STERRAD CYCLESURE 24 Biological Indicator (BI) || The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Dirección del fabricante
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA