Events

Rappel de Device Recall CoopeSurigcal

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 CooperSurgical, Inc..

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
    70368
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1397-2015
  • Date de mise en oeuvre de l'événement
    2013-05-01
  • Date de publication de l'événement
    2015-04-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133340
  • 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
    Pack, hot or cold, disposable - Product Code IMD
  • Cause
    Trans warmer infant and transport mattress not labeled with exp.Date may not meet specification.
  • Action
    CooperSurgical sent a formal recall notification letter dated April 4, 2015 to all affected customers. The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical notified consignees affected by this recall via Fedex with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. CooperSurigcal will replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Contact CooperSurgical at 203 601 5200 Ext. 3100 if you have questions. Previously CooperSurgical notified consignees affected by this recall on 5/1/13.

Device

Device Recall CoopeSurigcal
  • Modèle / numéro de série
    Product with no lot/ expiration date on the product label
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide - in the countries of:ARGENTINA, AUSTRALIA,BAHRAIN, ,BERMUDA,CANADA,COLOMBIA ,ENGLAND, GERMANY,HUNGARY,INDONESIA, KUWAIT,LATVIA,LIBYA,MALAYSIA MEXICO,NEW ZEALAND,SAUDI ARABIA. TURKEY, UNITED ARAB EMIRATES
  • Description du dispositif
    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel || P/N 20421 || Private label: || NovaPlus TransWarmer Infant Heat Therapy Mattress with || WarmGel. P/N V6390 || Provides warmth during transport of infant within the hospital || or between hospitals
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Adresse du fabricant
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Société-mère du fabricant (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA