Events

Rappel de Device Recall Presource PBDS, Gyn Laparoscopy Kit, Circulator

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 Cardinal Health, Medical Products & Services.

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
    64736
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1193-2013
  • Date de mise en oeuvre de l'événement
    2013-03-26
  • Date de publication de l'événement
    2013-05-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116902
  • 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
    Anesthesia breathing circuit kit - Product Code OFP
  • Cause
    Various presource kits contain a pre-assembled filter and anesthesia circuit that may contain outer plastic packaging on one or more components. if the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
  • Action
    Affected consignees were notified with a letter, dated March 26, 2013, sent via FedEx Priority, of this action. Cardinal Sales Representatives will also be advised and will verbally communicate the action to affected customers. The letter identified the affected product and the problem. Customers are to locate any affected product and quarantine them. In addition, clinicians should be informed of the issue; and, warning labels should be affixed to the front of each kit instructing users to remove and discard the Anesthesia Circuit and Filter Assembly. In order to confirm receipt of this action and completion of labeling the product, the enclosed Acknowledgement Form should be completed and returned to the number provided. If customers do now wish to accept overlabeled product or to overlabel the product in their possession, they are to contact Presource Sales Operations at 800-766-0706, or their sales representative for further instruction. Customers are to contact Cardinal Health Quality Systems at 800-292-9332, if they have any questions or need special assistance.

Device

Device Recall Presource PBDS, Gyn Laparoscopy Kit, Circulator

Manufacturer

Cardinal Health, Medical Products & Services
  • Adresse du fabricant
    Cardinal Health, Medical Products & Services, 1430 Waukegan Road, Attn V. Mueller Qa, Park City IL 60085
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA