Events

Rappel de Custom Convenience Kit

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 Merit Medical Systems, 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
    30343
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0191-05
  • Date de mise en oeuvre de l'événement
    2004-10-15
  • Date de publication de l'événement
    2004-11-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35697
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Cause
    Merit custom convenience kits contain monoject magellan safety needles which have been recalled by tyco healthcare.These needles may detach from their hub during use.
  • Action
    All consignees were notified by sales reps either by visit or telephone beginning 10/18/2004

Device

Custom Convenience Kit
  • Modèle / numéro de série
    Catalog # K09-00318FP, Lot # A348888 Catalog # K09-00378R, Lot #''s A335890, A337933, A339213, A342799, A345077, A347860. Catalog # k09-00946MP, Lot # A353710. Catalog # K09-01732HP, Lot #''s A341495, A348992. Catalog # K09-03251TP, Lot # A347976. Catalog # K09-05064D, Lot # A343197. Catalog # K09-05218BP, Lot # A347495. Catalog # K09-05475DP, Lot #''s A340512, A343609, A350138. Catalog # K09-05588C, Lot # A342348. Catalog # K09-05604DP, Lot #A339243. Catalog # K09-05608DP, Lot #''s A339690, A349600. Catalog # K09-05894F, Lot # A342805. Catalog # K09-07970A, Lot #''s A342665, A345567. Catalog # K09-08150AP, Lot #A340352. Catalog # K09-90100T, Lot # A353161. Catalog # K10-00091MP, Lot # A349569. Catalog # K10-01684BP, Lot # A352021. Catalog # K10-02936CP, Lot # A349696. Catalog # K10-03091B, Lot # A347572.  Catalog # K10-03237AP, Lot #''s A339280, A348945. Catalog # K10-03247P, Lot # A347910. Catalog # K10-03256P, Lot #''s A345788, A350183. Catalog # K10-03281P, Lot #''s A346956, A348009. Catalog # K12-01191C, Lot # A347022. Catalog # K12-01242P, Lot # A350194. Catalog # K12-01304P, Lot #''s A346945, A349053, A350907. Catalog # K12-01356P, Lot #''s A343540, A351436. Catalog # K12-01372P, Lot #''s A343539, A346944. Catalog # K12-01402P, Lot # A352329. Catalog # K12-01427P, Lot # A352036. Catalog # K12-01507P, Lot #''s A349066, A351446. Catalog # K12-01512, Lot # A348216. Catalog # K12-01560, Lot # A347564.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. No foreign distribution
  • Description du dispositif
    Custom Convenience Kit
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • Adresse du fabricant
    Merit Medical Systems, Inc, 1600 West Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA