Events

Rappel de Centurion Sterile 84 Rubber Bands

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
    66830
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0464-2014
  • Date de mise en oeuvre de l'événement
    2013-10-28
  • Date de publication de l'événement
    2013-12-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123693
  • 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
    Device, general medical - Product Code LDQ
  • Cause
    Package labeling indicates both "latex free" and "contains natural rubber latex" . the rubber bands do contain natural rubber latex. this could cause a significant risk to users with latex allergies.
  • Action
    Centurion sent a Urgent Recall Notification letter via Certified Mail October 31, 2013, return receipt to all affected customers. The affected Centurion Medical Products Corporation sales representatives were notified via email on October 28, 2013. Customers were instructed to destroy all implicated product and complete the accountability record included with the notice and fax to 517-546-3356. Customers were asked to forward a copy of the notice if product was further distributed. Additional notices will be mailed to non-responsive customers via Certified Mail Return Receipt, and will be documented in the recall file. For further questions please call (517) 546-5400.

Device

Centurion Sterile 84 Rubber Bands
  • Modèle / numéro de série
    EB84, Lot 2013041801 Expriation 2018/03
  • Distribution
    US Distribution including the states of GA, LA and NY.
  • Description du dispositif
    Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. || LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN || Single Use Only || bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Adresse du fabricant
    Centurion Medical Products Corporation, 301 Catrell Dr, Howell MI 48843-1703
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA