Events

Rappel de 3M Scotchcast

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 3M Company - Health Care Business.

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
    66052
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2242-2013
  • Date de mise en oeuvre de l'événement
    2013-08-05
  • Date de publication de l'événement
    2013-09-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121377
  • 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, cast - Product Code ITG
  • Cause
    3m is conducting a voluntary product recall of selected lots of 3m" scotchcast" wet or dry cast padding. upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. lack of repellency may result in prolonged cast dry times after exposure to wet conditions. there have been no repo.
  • Action
    3M sent a Voluntary Product Recall Notification letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to examine their inventory and set aside any affected lots subject to the recall notice. Customers were asked to inform all departments of any affected lots and provide them with a copy of the Notification letter that instructs them to contact their 3M distributor for alternative options. All affected products were to be returned to the 3M distributor they were purchased from. Customers with questions were instructed to contact the 3M Customer Helpline at 1-800-228-3957. For questions regarding this recall call 651-733-1110.

Device

3M Scotchcast
  • Modèle / numéro de série
    Catalog # - Lot # WDP2 - 792920, 793090, 793640 & 796078. WDP3 - 792921, 793098, 793638, 796077 & 798487. WDP4 - 792922, 793116, 793637, 796079 & 798488. WDP6 792923, 793636, 798489, 799235 & 799236
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, AR, CA, CO,CT, FL, GA, HI, IL, IN,KS,KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OR,PA, TN, TX, UT,VA, WA, and WI. Internationally to GERMANY, CANADA, BELGIUM, NETHERLANDS, HONG KONG, NEW ZEALAND, AUSTRALIA, INDIA, KOREA, SINGAPORE AND UNITED ARAB EMIRATES, JAPAN, JAMAICA..
  • Description du dispositif
    3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. || Intended for use in constructing casts for either wet or dry immobilization.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Adresse du fabricant
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    USFDA