Events

Rappel de Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.

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 Kimberly-Clark Corporation.

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
    35559
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1242-06
  • Date de mise en oeuvre de l'événement
    2006-05-18
  • Date de publication de l'événement
    2006-07-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-05-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46395
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Cause
    The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.
  • Action
    Consignees were first contacted by phone with follow up letter sent via fax or mail on May 18, 2006. International consignees will be notified through the firm's regional offices.

Device

Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode product...
  • Modèle / numéro de série
    Catalog number 30-585, Lot number 300847; Catalog number 30-590 Lot numbers 28802, 297261, 304750; Catalog number 30-591, Lot number 299214; Catalog number 30-593, Lot number 288962, 293213, 294860, 302657; Catalog number 3100-1702, Lot number 297735; Catalog number 3100-703, Lot number 282936, 293214, 300849, 303000; Catalog number 3111-1721, Lot numbers 282181, 282938, 286332, 286339, 288964, 288970, 290318, 290905, 291535, 292660, 293217, 294206, 294862, 295600, 296270, 297263, 298032, 299985, 302659, 303003, 304091, 304753, 305509;  Catalog number 3112-1731, Lot numbers 282183, 282939, 285955, 286335, 286342, 290320, 290907, 291537, 292662, 293220, 294208, 294866, 295603, 296273, 299218, 299987, 300853, 304093, 305512; Catalog number 3114-1741, Lot numbers 282185, 284030, 290322, 291538, 292664, 295604, 297266, 300854, 304095; Catalog number 3200-1715, Lot numbers 282188, 282942, 284031, 288004, 288005, 288966, 288967, 288974, 288975, 290911, 291541, 292667, 293224, 294210 294870, 295607, 296276, 297269, 298038, 299221, 299991, 301444, 302665, 303008, 304097, 304757, 305515;  Catalog number 3250-1780, Lot numbers 292086, 297270, 301445, 302666.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)
  • Description du dispositif
    Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Adresse du fabricant
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA