Retiro De Equipo (Recall) de Device Recall KY LIQUIBEADS Vaginal Moisturizer

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 Mc-NEIL-PPC, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Lubricant, patient, vaginal, latex compatible - Product Code NUC
  • Causa
    Johnson & johnson healthcare products (jjhp) is voluntarily recalling this product to address fda concerns that the product should have been cleared under a separate medical device application. this voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to k-y liquibeads. jjhp received a warning letter on may 23, 2012 indicating that thi.
  • Acción
    Johnson & Johnson sent Recall Letters/Response forms dated June 29, 2012 on July 2, 2012. The recall notification included affected lots and instructions for wholesale distributors and retailers that handle the product. The recalled product is being handled by Stericycle. The notification included phone and fax numbers in the event assistance is required. Customers were asked to complete the enclosed business Reply Form and return immediately; identify all warehouse/wholesale inventories of products and return immediately per the attached "Return Authorization Form." For any questions regarding the form, customers were asked to call Stericycle at 888-406-9309. Customers could also fax questions to 877-877-0318. Once customers have collected all returns, they should send back immediately per the enclosed instructions. For questions regarding this recall call 908-874-1000.


  • Modelo / Serial
    The following Lot Numbers were identified: 2721W; 2591W; 2321W; 1681W; 0921W; 0651W; 0471W; 0361W; 0221W; 0041W; 0110H; 0100H; 0090H; 0080H; 0030H; 0179H; 0159H; 0219H and 3489RT.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. || Personal lubricant
  • Manufacturer


  • Dirección del fabricante
    Mc-NEIL-PPC, Inc., 199 Grandview Rd, Skillman NJ 08558-1311
  • Empresa matriz del fabricante (2017)
  • Source