Events

Rappel de Centurion

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
    70081
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0945-2015
  • Date de mise en oeuvre de l'événement
    2014-10-23
  • Date de publication de l'événement
    2015-01-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132234
  • 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
    Cardiovascular surgical instruments tray (kit) - Product Code OFA
  • Cause
    According to the recall notice received from hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
  • Action
    Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.

Device

Centurion
  • Modèle / numéro de série
    CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
  • Description du dispositif
    Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
  • 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