Events

Retiro De Equipo (Recall) de Device Recall Vinyl PowderFree Exam Gloves

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 Gulf South Medical Supply 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
    63603
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0295-2013
  • Fecha de inicio del evento
    2012-06-20
  • Fecha de publicación del evento
    2012-11-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114353
  • 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
    Glove, Patient Examination Vinyl - Product Code LYZ
  • Causa
    Gulf south medical supply recalled their select medium and large size vinyl exam gloves because they were inadvertently shipped prior to u.S. customs clearing them for sale.
  • Acción
    The firm, PSS World Medical, sent an "URGENT RECALL NOTICE" dated June 20, 2012 via USPS to all customers that received the product. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, quarantine the affected lot numbers listed in this recall and return the product; If the product was further distributed, to inform their customers of the recall and request they return the affected product directly to them; and contact their Gulf South Customer Care team via telephone at 1-800-347-2456 or email to customercare@gsms.com to request a return goods authorization. If you have any questions, contact the Product Integrity Leader Quality Assurance at 904-380-4501.

Device

Device Recall Vinyl PowderFree Exam Gloves
  • Modelo / Serial
    Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
  • Descripción del producto
    Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. || Usage: Patient Examination.
  • Manufacturer
    Gulf South Medical Supply Inc

Manufacturer

Gulf South Medical Supply Inc
  • Dirección del fabricante
    Gulf South Medical Supply Inc, 4345 Southpoint Blvd, Jacksonville FL 32216-8013
  • Source
    USFDA