Events

Rappel de Merit Medical Surgical Convenience Kits

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
    38950
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1262-2007
  • Date de mise en oeuvre de l'événement
    2007-08-15
  • Date de publication de l'événement
    2007-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54603
  • 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
    Surgical Convenience Kits - Product Code LRO
  • Cause
    Expiration dating; some convenience kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.
  • Action
    An August 22, 2007, Product Correction/Removal letter was issued to all distributors requesting return of affected lots and sub recall notification to their consignees.

Device

Merit Medical Surgical Convenience Kits
  • Modèle / numéro de série
    Merit Lot Numbers: A339685, A342805, A343855, A344934, A348869, A350784, A350904, A353811, A355556, A357384, A357617, A358608, A360773, A361301, A364800,A365752, A366125, A366523, A367651, A371190, A372815, A374857, A375138, A375848, A376973, A377976, A381997, A384786, A387975, F390117, F399800, F406192, F434870, F440785, F440789, F440801, F440803, F442051, F449479, F449481, F449482, F449483, F453020, F453170, F455150, F456553, F465539, F465540, F470421, F471056, F471659, F473566, F474320, F476314, F476367, F476543, F476597, F477729, F480127, F480129, F480131, F480140, F482129, F482853, F488460, F488709, F488858, F489432, F491275, F491462, F491656, F491659, F492220, F492223, F494547, F495828, F496118, F496939, F502345, F504184, F505776, F505782, F505785, F505786, F505790, F505794, F505799, F508595, F509197, F511015, F513651, F514433, F514954, F514957, F515853, F517537, F517708, F518306, F520504, F523595, F526626, F528413, F534059, F536871, F537731, F538716, F548977, F548978.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
  • 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