Events

Retiro De Equipo (Recall) de Device Recall CareFusion Wet PVPI Preoperative Skin Prep Tray

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 Carefusion 2200 Inc.

¿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
    61103
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1208-2012
  • Fecha de inicio del evento
    2012-02-07
  • Fecha de publicación del evento
    2012-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107312
  • 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
    Skin prep tray (kit) - Product Code OJU
  • Causa
    The povidone-iodine (pvp-i) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (eo) sterilant and/or by-products within the pvp-i solution, which may represent a patient safety hazard.
  • Acción
    CareFusion sent e-mails and follow-up Urgent Recall Notices dated February 7, 2012 to all of the affected customers on the same date, requesting that the customers follow the steps outlined below as mitigation until product can be replaced. 1. Please immediately destroy/discard or return any affected product you may have in-stock at your facility. Do NOT further distribute these products. 2. Forward this RECALL NOTICE to any customers to whom these products were sold notifying them of the potential risk (reference attachment for affected production lot numbers). End users must be advised to discard or return any CareFusion Skin Prep Tray with the noted product/lot number; distributors should manage this return process per their internal procedures. End users MUST NOT use these products. 3. Complete and return the attached Acknowledgement Form indicating that they have received this RECALL NOTICE and that they will communicate the Recall Notice to all customers who have purchased CareFusion Preoperative Skin Prep Tray catalog numbers 4420, 4468, and 4469A. 4. Contact CareFusion Customer Service at (800) 523-0502 ext. 53576 for details on return and/or replacement of stock.

Device

Device Recall CareFusion Wet PVPI Preoperative Skin Prep Tray
  • Modelo / Serial
    tray catalog number 4468. tray lot numbers 0000310407, 0000310409, 0000310411, 0000310413, 0000312077, 0000312080, 0000312081, 0000313225, 0000313227, 0000313229, 0000313233, 0000313523, 0000314761, 0000314762, 0000315476, 0000315477, 0000315478, 0000315480, 0000317227, 0000317229, 0000317230, 0000317231, 0000318349, 0000318350, 0000318351, 0000318352, 0000319401, 0000319402, 0000319403, 0000319404, 0000319405, 0000321997, 0000321998, 0000321999, 0000322000, 0000322001, 0000323739, 0000323740, 0000323741, 0000326095, 0000326097, 0000326099, 0000326100, 0000326101, 0000326103, 0000326104, 0000328472, 0000328473, 0000328474, 0000328475, 0000328497, 0000328502, 0000328504, 0000330880, 0000330881, 0000330884, 0000330885, 0000330886, 0000333712, 0000333754, 0000333755, 0000333756, 0000333757, 0000333758, 0000333759, 0000333761, 0000333762, 0000336431, 0000336433, 0000336434, 0000336435, 0000336437, 0000336439, 0000336442, 0000336448, 0000336449, 0000336450, 0000336451, 0000336452, 0000336453, 0000342781, 0000342782, 0000342783, 0000342785, 0000342786, 0000342787, 0000342788, 0000342789, 0000342790, 0000344054, 0000344798, 0000344800, 0000344810, 0000344811, 0000344812, 0000347086, 0000347087, 0000347088, 0000347090, 0000347091, 0000347093, 0000347094, 0000347095, 0000347096, 0000349465, 0000349466, 0000349467, 0000349473, 0000349812, 0000351290, 0000351684, 0000351687, 0000354085, 0000354087, 0000354089, 0000354091, 0000354096, 0000354100, 0000356292, 0000356294, 0000356296, 0000356299, 0000356300, 0000361254, 0000361255, 0000361284, 0000615475, Y1051567, Y10S2362, Y10S2363, Y10S2370, Y10S2371, Y10S2372, Y10S2402, Y10S2436, Y10S2988, Y10S2989, Y10S2990, Y10S3008, Y10S3011, Y1053012, Y10S3118, Y10S3119, Y11A0340, Y11A0341, Y11A0347, Y11A0349, Y11A1125, Y11A1139, Y11A1147, Y11A1148, Y11A1155, Y11A1270, Y11A1980, Y11A1981, Y11A1982, Y11A2013, Y11A2014, Y11A2637, Y11A2638, Y11A2639, Y11A2729, Y11A2733, Y11A2734, Y11A3238, Y11A3239, Y11A3240, Y11B0276, Y11B0279, Y11B0290, Y11B0411, Y11B0603, Y11B0949, Y11B0959, Y11B0960, Y11B0961, Y11B1240, Y11B1241, Y11B1427, Y11B1651, Y11B2564, Y11B2566, Y11B2925, Y11B2927, Y11B2928, Y11B2932, Y11C0274, Y11C0275, Y11C0283, Y11C0284, Y11C0318, Y11C0319, Y11C0320, Y11C1275, Y11C1276, Y11C1277, Y11C1278, Y11C1280, Y11C1976, Y11C1977, Y11C2146, Y11C2147, Y11C2865, Y11C3085, Y11C3086, Y11C3103, Y11C3104, Y11C3105, Y11C3141, Y11C3142, Y11C3744, Y11C3745, Y11C3746, Y11C3752, Y11D0541, Y11D0542, Y11D0777, Y11D0778, Y11D0783, Y11D0784, Y11D0785, Y11D0786, Y11D0787
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including Arizona, California, Colorado, Connecticut, Florida, Illinois, Missouri, Nebraska, Nevada, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah and Virginia.
  • Descripción del producto
    Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4468 || The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Dirección del fabricante
    Carefusion 2200 Inc, 1500 Waukegan Rd, Mpwm Bldg., McGaw Park IL 60085-6728
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA