Events

Rappel de Device Recall KimberlyClark, Three Quarter Drape

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
    59161
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2836-2011
  • Date de mise en oeuvre de l'événement
    2011-06-06
  • Date de publication de l'événement
    2011-07-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101449
  • 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
    Surgical Drape - Product Code KKX
  • Cause
    Metal shavings were found within the folded portion of the surgical drape.
  • Action
    Kimberly-Clark Corporation sent an "Urgent: Voluntary Product Recall" letter dated June 6, 2011 to all affected customers and a subsequent letter dated June 22, 2011. The letter notified them of the recall and provided recommendations. They were instructed to evaluate their facilities unused inventory of the affected drapes to determine if any of the impacted product lots remain with their facility. If present, they were to quarantine and discontinue use. A Customer Product Recall Response Form was included to be completed and faxed to KC. They will be contacted by a representative regarding the return and replenishment of the product. If the product was further distributed, the consignee was advised to contact the end user, make them aware of the recall and to retrieve any of the affected product in inventory. For additional information please contact Kimberly-Clark Regulatory Affairs at 770-587-7400.

Device

Device Recall KimberlyClark, Three Quarter Drape
  • Modèle / numéro de série
    Product Code: 79147 Lot numbers: AC1080052, AC1093104, AC1094061, AC1098193, AC1099073, AC1099213, AC1099074, AC1100074, AC1105054, AC 1124031, AC1124092, AC1126173, AC 1127013, AC 1128153, AC1129031, AC1129062, AC1130011, AC1130092, AC1082042, AC1089111, AC1102021 AC1102141, AC1103031, AC1104101, AC1106103, AC1106164, AC1107084, AC1121184, AC1122071, AC1122192, AC1123012, AC1125111, AC1131082, AC1131092, AC1131151, AC1134133.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI.
  • Description du dispositif
    Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, || Surgical drape.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

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