Device Recall Custom Procedural Trays

  • Modèle / numéro de série
    Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: US including states of: NE and SD.
  • Description du dispositif
    Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 || A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Merit Medical Systems, Inc., 12701 N Kingston Ave, Chester VA 23836-2700
  • Société-mère du fabricant (2017)
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Military Hospital on base in Landstuhl, Germany
  • Description du dispositif
    Custom Procedural Trays: Merit's Custom Angio Kits || A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
  • Manufacturer