Events

Retiro De Equipo (Recall) de Device Recall TempPad Cold Therapy Pad .

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 Cincinnati Sub-Zero Products 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
    53947
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0782-2010
  • Fecha de inicio del evento
    2009-11-14
  • Fecha de publicación del evento
    2010-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86950
  • 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
    Pack, Hot or cold, Water Circulating - Product Code ILO
  • Causa
    Product is labeled as "sterile". it was observed that incomplete seals were created in the packaging materials during production. when the seal is compromised, the sterility of the product inside the package cannot be assured.
  • Acción
    On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.

Device

Device Recall TempPad Cold Therapy Pad .
  • Modelo / Serial
    Part #: 50625, Catalog number: 510-US, Lot #: 08296, 08529, 08530, 08531, 08674, 08759, 08826, 08952, 09052, 09166, 09422, 09423; Part #: 50633, Catalog #: 510-USS, Lot #: 08537, 08675, 08953; Part #: 50627, Catalog #: 814-US, Lot #: 08610; Part # 50634, Catalog # 814-USS, Lot #: 08611, 08919, 09466; Part #: 50628, Catalog #: 1112-US, Lot #'s: 08382, 08411, 08475, 08476, 08477, 08557, 08583, 08657, 08666, 08667, 09486, 08668, 08707, 08771, 08810, 08874, 08903, 08971, 09037, 09088, 09089, 09149, 09225, 09251, 09285, 09313, 09314, 09327, 09360, 09361, 08320; Part #:50635, Catalog #: 1112-USS, Lot #'s: 08410, 08514, 08606, 08673, 08708, 08772, 08802, 08868, 08954, 09017, 09066, 09067, 09195, 09253, 09254, 09295, 09377, 09378, 09485, 08331; Part #: 50629, Catalog #: 1215-US, Lot #'s: 08395, 08584, 08669, 08732, 08917, 08989, 09107, 09218 & Part #: 50137, and Catalog #: CT-99, Lot #'s: 08332, 08353, 08438, 08538, 08607, 08608, 08706, 08725, 08773, 08837, 08851, 08879, 08933, 08970, 09010, 09086, 09087, 09143, 09144, 09157, 09294, 09329, 09362, 09379 and 08423.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
  • Descripción del producto
    TempPad¿ Cold Therapy Pad. || The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Dirección del fabricante
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    USFDA