Events

Rappel de Device Recall Phantom black latex powderfree gloves

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 Adenna 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
    60894
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0712-2012
  • Date de mise en oeuvre de l'événement
    2011-12-22
  • 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
    2012-05-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106728
  • 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
    Latex patient examination glove - Product Code LYY
  • Cause
    The recall was initiated because adenna inc. distributed latex gloves that have been fda refused.
  • Action
    Adenna Inc. sent a recall letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and quarantine the products that are subject to the recall. Customers were instructed to notify their customers if they have further distributed the products. Customers were instructed to cease using the recalled products, and Adenna will replace the products. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with any questions can contact their account manager at (888) 3ADENNA (1-888-323-3662) for futher assistance.

Device

Device Recall Phantom black latex powderfree gloves
  • Modèle / numéro de série
    Lot No. 002-E1LF302-1 and Lot No. 002-E1LF305-1
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of: FL, CA, NY, NV, NC, MD, TX, OR, AZ, OH, MN, and IL.
  • Description du dispositif
    Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, || Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small || Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium || Examination Disposable Gloves
  • Manufacturer
    Adenna Inc

Manufacturer

Adenna Inc
  • Adresse du fabricant
    Adenna Inc, 201 S Milliken Ave, Ontario CA 91761-7832
  • Société-mère du fabricant (2017)
    Adenna Inc.
  • Source
    USFDA