Events

Rappel de Device Recall Standard Drip Administration Set

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 Smiths Medical Asd 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
    47474
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1549-2008
  • Date de mise en oeuvre de l'événement
    2008-03-24
  • Date de publication de l'événement
    2008-07-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69548
  • 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
    IV Sets - Product Code LHI
  • Cause
    Misbranded/mispackaged device was distributed. product labeled to contain 72 inch standard drip ( iv) administration sets, actually contained 60 inch (iv) administration sets with a' y' site.
  • Action
    On 3/24/2008, the firm issued separate URGENT: PRODUCT RECALL NOTIFICATIONs sent via certified mail to their distributor and medical customers. Both recall notifications inform the customers of this labeling error and ask that the customers: 1) check their inventories for the presence of the suspect product; 2) complete and return the attached 'Product Recall Notification Response Form'; and 3) make arrangements to return any unused affected product to the recalling firm in exchange for a credit or replacement product. In addition, the distributors are asked to either provide the recalling firm with a list of their sub-account customers so that Smith Medical can contact the enduser customers and notify them of the recall, or as an alternative measure, the distributor can notify their branches and customers directly, via their own certified letter.

Device

Device Recall Standard Drip Administration Set
  • Modèle / numéro de série
    Lot #1217947.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of PA, NJ, IL, MN and ND and country of Canada.
  • Description du dispositif
    Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. || Used to administer fluids.
  • Manufacturer
    Smiths Medical Asd Inc

Manufacturer

Smiths Medical Asd Inc
  • Adresse du fabricant
    Smiths Medical Asd Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA