Events

Rappel de Device Recall Ambitex NMD400 Nitrile Exam 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 Cardinal Health.

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
    72078
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0133-2016
  • Date de mise en oeuvre de l'événement
    2015-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140214
  • 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
    Polymer patient examination glove - Product Code LZA
  • Cause
    Ambitex nitrile nmd400 exam gloves size medium on exam hold were inadvertently placed into commerce. the product was under exam hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by fda as described at 21 cfr 800.20.
  • Action
    The firm sent an Urgent: Product Recall letter dated 8/25/2015. The firm is requesting the user discontinue using and return any remaining stock of the AMBITEX Nitrile Exam Gloves because the gloves were inadvertently shipped prior to U.S. FDA releasing them for sale. Additionally, the firm requests that the customer quarantine the affected examination gloves; and return a copy of the enclosed Acknowledgment Form confirming their receipt of the Urgent recall via fax to 216-651-9760. Customer Service should be contacted at 800-GLOVES-0 to arrange for the return and credit of any on hand product that customer may have. If the customer has further distributed the affected gloves they are advised to notify their customers of the recall.

Device

Device Recall Ambitex NMD400 Nitrile Exam Gloves
  • Modèle / numéro de série
    Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. || Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Adresse du fabricant
    Cardinal Health, 1300 Waukegan Rd, Waukegan IL 60085-6724
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA