Device Recall Custom Bone Marrow Tray for Hackensack University Medical Center

  • Modèle / numéro de série
    Catalog # CB0370 Lot Number(s): 83151QUJ; 90551SU7; 0090207T; 028123D7.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
  • Description du dispositif
    Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 2 -10cc Syringe L/L; 1 - Male Luer Cap; 1 - Glass Slide Poly Bag; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides Frosted end; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - CSR Wrap***Catalog Number: CB0370***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, customer_service@angio.com, www.angiotech.com. || Intended for the purpose of harvesting bone and/or bone marrow specimens.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Société-mère du fabricant (2017)
  • Source
    USFDA