Device Recall TLok Bone Marrow Tray w/ Safety Needles

  • Modèle / numéro de série
    Catalog # BMT1104STL Lot Number(s): 91341UEU; 91341UEV; 91911VK5; 92381WHL; 92571WRG; 92661WYL; 92661WYM; 92661WYR; 92851XBE; 00671ZRE; 0078200R; 00912094; 013020WN; 017921PT; 022822HZ; 02602314; 029923PV.
  • 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***T-Lok Bone Marrow Tray w/ Safety Needles***1 - #11 Retractable Scalpel; 1 - 21ga x 1-1/2" Safety Needle; 1 - 25ga x 5/8" Safety Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Specimen Label; 5 - 3" x 3" Sponges (4-Ply); 1 - CSR Wrap; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Stirring Rod; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 -Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Towel; 3 - NeedleVISE***Catalog Number: BMT1104STL***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