Devices

Device Recall DeRoyal Sterile Custom kits

  • Modèle / numéro de série
    (a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to states of: CA and MO.
  • Description du dispositif
    DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: || (a) Shoulder Arthroscopy Pack 89-8686.01 || (b) Shoulder Arthroscopy Pack 89-8686.02 || (c) Knee Arthro Pack 89-8687.01 || (d) Knee Arthro Pack 89-8687.02 || Product Usage: general surgical
  • Manufacturer
    DeRoyal Industries Inc
  • 1 Event

Fabricant

DeRoyal Industries Inc
  • Adresse du fabricant
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Société-mère du fabricant (2017)
    Deroyal Industries Inc.
  • Source
    USFDA