Events

Rappel de Device Recall IPI & Medex Disposable Oxygen Mask & Bag

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 Medex 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
    29496
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1126-04
  • Date de mise en oeuvre de l'événement
    2004-07-12
  • Date de publication de l'événement
    2004-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33855
  • 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
    Mask, Oxygen, Non-Rebreathing - Product Code KGB
  • Cause
    The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
  • Action
    Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.

Device

Device Recall IPI & Medex Disposable Oxygen Mask & Bag
  • Modèle / numéro de série
    reorder no. 7020, lots K235, K277A, J135R, J142, M196, M337, N107
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.
  • Description du dispositif
    Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
  • Manufacturer
    Medex Inc

Manufacturer

Medex Inc
  • Adresse du fabricant
    Medex Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Source
    USFDA