Events

Rappel de Protective Wipes (aqueous formulation)

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-2748-2011
  • 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=99515
  • 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
    Bandage, liquid - Product Code KMF
  • 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

Protective Wipes (aqueous formulation)
  • Modèle / numéro de série
    Lot #  9K150,  9K151,  9L169,  9L170,  0E230,  0E231,  0J290,  0J291,  0J292.
  • 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
    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.
  • 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