Events

Rappel de Device Recall Zee Clear Vinyl Medical Examination Gloves, Medium

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 Cypress Medical Products LLC.

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
    60552
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0679-2012
  • Date de mise en oeuvre de l'événement
    2011-11-15
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105790
  • 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
    Vinyl patient examination glove - Product Code LYZ
  • Cause
    The gloves fail to meet the performance requirements of 21 cfr 800.20 for leakage defects.
  • Action
    Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.

Device

Device Recall Zee Clear Vinyl Medical Examination Gloves, Medium
  • Modèle / numéro de série
    Zee Part No.: 3061, lot number CZA04-22
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including California, Indiana, New York and Texas
  • Description du dispositif
    Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3061 || Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
  • Manufacturer
    Cypress Medical Products LLC

Manufacturer

Cypress Medical Products LLC
  • Adresse du fabricant
    Cypress Medical Products LLC, 1202 S Il Route 31, Mchenry IL 60050
  • Société-mère du fabricant (2017)
    Mckesson Corporation
  • Source
    USFDA