Events

Retiro De Equipo (Recall) de Protective Wipes (aqueous formulation)

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 Smith & Nephew 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
    58525
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2748-2011
  • Fecha de inicio del evento
    2011-04-04
  • Fecha de publicación del evento
    2011-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99515
  • 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
    Bandage, liquid - Product Code KMF
  • Causa
    Smith & nephew, inc., st. petersburg, fl is recalling multiple lot numbers of the following products: remove universal adhesive remover wipes, uni-solve adhesive remover wipes, skin-prep protective wipes, peri-prep protective wipes, and no-sting skin-prep protective wipes. these products were manufactured by h&p; industries dba the triad group who has initiated a recall of products manufactured i.
  • Acción
    Smith & Nephew Inc. sent an "URGENT DEVICE CORRECTION" letter dated April 8, 2011 to all customers who received the recalled products. The letter described the product, problem and the appropriate actions to be taken. Customers are instructed to immediately discontinue using the recalled products, examine their inventory, and follow the return or disposition instructions provided. The letter instructed customers to seek an alternative product for use. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271.

Device

Protective Wipes (aqueous formulation)
  • Modelo / Serial
    Lot #  9K150,  9K151,  9L169,  9L170,  0E230,  0E231,  0J290,  0J291,  0J292.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of: NC, PA, NM, OR, VA, TN, NY, OR, AL, IL, MN, TX, and Puerto Rico and the countries of: Australia, Canada, England, France, Germany, Hong Kong, Japan, Mexico, New Zealand, Singapore, South Africa, Taiwan, and United Kingdom
  • Descripción del producto
    smith&nephew; NO-STING SKIN-PREP No-Sting Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping Improves tape, film and appliance adhesion No-sting, non-irritating Reduces friction:Packaged 50 wipes per box. || Formulation No. F-63, Product code 59420600 || ----- || Device Kits containing NO-STING SKIN-PREP Pouch || Package Label: 12 month shelf life || REF 66800882***RENASYS-G/P Gauze Dressing Kit with Port Small Kit***Rx only CE***.Case Label: REF 66800882 QTY 15***. || ----- || Package Label: 12 month shelf life || REF 66800883***RENASYS-G/P Gauze Dressing Kit with Port Medium Kit*** Rx only CE***. Case Label: REF 66800883 QTY 15***. || ----- || Product Label: 12 month shelf life || REF 66800884***RENASYS-G/P Gauze Dressing Kit with Port Large Kit*** Rx only CE***. Shipping Label: REF 66800884 QTY 15***. || ----- || Product Label: 9 month shelf life || REF 66800491***RENASYS-G Gauze Dressing Kit - Small 10 Fr Round Drain*** CE***Rx only***. Case Label: REF 66800491 QTY 15***. || ----- || Product Label: 9 month shelf life || REF 66800492***RENASYS-G Gauze Dressing Kit - Small 10mm Flat Drain*** ***Rx only CE ***. Case Label:REF 66800492 QTY 15***. || ----- || Product Label: 9 month shelf life || REF 66800493***RENASYS-G Gauze Dressing Kit - Medium 15 Fr Channel Drain*** ***Rx only CE ***. Shipping Label: REF 66800493 QTY 15***. || ----- || Product Label: 9 month shelf life || REF 66800494***RENASYS-G Gauze Dressing Kit - Medium 10mm Flat Drain*** Shipping Label: 66800494 QTY 15***. || ----- || Product Label: 9 month shelf life || REF 66800495***RENASYS-G Gauze Dressing Kit - Large 19 Fr Round Drain*** **Rx only***. Shipping Label: REF 66800495 QTY 15***. || ----- || Product Label: 9 months shelf life || REF 66800496***RENASYS-G Gauze Dressing Kit - Large 10mm Flat Drain*** ***Rx only CE ***. Shipping Label: REF 66800496 QTY 15***. || ------ || Package Labeling: 9 months shelf life || ***REF 66800212***HIGH OUTPUT / FISTULA KIT Irrigation/Aspiration Drain - 28 Fr WOODING-SCOTT Technique***Rx Only CE ***. Shipping Label: REF 66800212 QTY 10***. || ------ || Product Usage: No-Sting Skin-Prep is indicated as an effective barrier between skin and tape.
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.
  • Dirección del fabricante
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA