Events

Rappel de Device Recall MultiLumen PI CVC Kit and PSI Kit

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 Arrow International 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
    70017
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1005-2015
  • Date de mise en oeuvre de l'événement
    2014-12-16
  • Date de publication de l'événement
    2015-01-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132116
  • 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
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Cause
    The instructions for use (ifu) were inadvertently removed from the kit.
  • Action
    An Urgent Medical Device Corrective Action Notification letter, dated December 16, 2014, was sent to Owens & Minor, 1605 Worldwide Blvd., Hebron, KY 41048-8653, instructing them to immediately discontinue distribution and quarantine any products, use customer letter and Corrective Action Acknowledgement Form templates to communicate this corrective action to any of thier customers that have received product included within the scope of the corrective action, and to have their customers return a completed Corrective Action Acknowledgement Form outlining their remaining inventory of the affected product codes and lot numbers for which replacement IFUs is needed.

Device

Device Recall MultiLumen PI CVC Kit and PSI Kit
  • Modèle / numéro de série
    Multi-Lumen PI CVC Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015  PSI Kit: 8.5 FR X 4-1/8 (10 CM), product code ASK-09803-OSU2 , lot #23F14C1014, exp. 31-Aug-2015:
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    In the state of KY
  • Description du dispositif
    Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: || Product Usage: || Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA