Events

Rappel de Device Recall Dressing Change Tray for Hickman & Dialysis Catheters

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 Centurion Medical Products 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
    57767
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1463-2011
  • Date de mise en oeuvre de l'événement
    2011-01-14
  • Date de publication de l'événement
    2011-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97366
  • 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
    Kit, wound dressing - Product Code MCY
  • Cause
    The firm is conducting a subrecall of kits containing triad groups alcohol prep pads. triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, bacillus cereus.
  • Action
    The firm, Centurion Medical Products, sent an "URGENT PRODUCT RECALL NOTICE" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: lcarpenter@centurionmp.com. The notice states that a Centurion representative will contact them regarding retrieval of the product from the facility. Should your require additional information, please contact the Director of Quality Assurance & Regulatory Affairs at (517) 546-5400 ext. 1135.

Device

Device Recall Dressing Change Tray for Hickman & Dialysis Catheters
  • Modèle / numéro de série
    2010031590, 2010122090, 2010012590.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC.
  • Description du dispositif
    Dressing Change Tray for Hickman & Dialysis Catheters, DT12110, Sterile, Centurion Medical Products Corp., Williamston, MI. || These kits are used for dressing changes.
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Adresse du fabricant
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA