Events

Rappel de Adhesive Remover Wipe

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Smith & Nephew Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58525
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2750-2011
  • Date de mise en oeuvre de l'événement
    2011-04-04
  • Date de publication de l'événement
    2011-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99520
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Solvent, adhesive tape - Product Code KOX
  • Cause
    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.
  • Action
    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

Adhesive Remover Wipe
  • Modèle / numéro de série
    UNISOLVE 402300 Lot #  0F195,  0F197,  0F198,  0F223,  0F224,  0F228,  0F229,  0F239,  0H185,  0H226,  0H228,  0H229,  0K207,  0K208,  0K209,  0K233,  0K234,  0M136,  0M137,  0M151,  0M238,  1A103,  1B129,  1B130,  1B131,  1B132.   REMOVE CE 59403125:  0E219,  0E226,  0F242,  0G116,  0H256,  0J233,  0J262,  0J263,  0M178,  0M179,  1A106,  1A181,  1A182,  1A192.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    Brand: UNI-SOLVE Adhesive Remover Wipe  Pouch, 50 Count Box Label || ***smith&nephew;***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. || Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: || smith&nephew; Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** || -------------------- || Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: || ***smith&Nephew;***#59403125***REMOVE***US Patent no. 5336207***CE***. || Formulation F-57 S&N; Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. || Formulation F-57 S&N; Product Code 59403125 REMOVE CE Adhesive Remover. || Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. || .
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.
  • Adresse du fabricant
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA