Device Recall ARROW OnControl

  • Modelo / Serial
    Material # 9408-VC-006, Lot numbers: 010256, 010257, 010438, 010439, 010556, 010557, 010737, 010738, 010739, 010946, 010947, 011037, 011046, 011047, 011048, 011215, 011216, 011217, 011380, 011381, 011383, 011384, 011385, 011675, 011676, 011945, 011946, 011947, 012139, 012140, 012141, 012142, 012353, 012354, 012355, 012356, 012463, 012464, 012465, 012570, 012572, 012573, 012686, 012687, 012688, 012895, 012896, 013074, 013084, 013085, 013122, 013185, 013255, 013256, 013257, 013258, 013477, 013478, 013688, 013894, 013895, 013896, 013897, 014111, 014112, 014113, 014114, 014115, 014134, 014135, 014136, 014199, 014200, 014201, 014202, 014306, 014307, 014308, 014420, 014422, 014423, 014569, 014570, 014571, 014703 & 014805 and Material #9411-VC-006, Lot numbers: 010184, 010440, 010559, 010949, 011052, 011218, 011374, 011386 011720, 011948, 012352, 012459, 012578, 012689, 012894, 013060, 013246, 013468, 013509, 013689, 013891, 014121, 014139, 014168, 014197, 014203, 014310, 014425 & 014617.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Descripción del producto
    ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, || The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

3 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Material # 9451-VC-006, Lot numbers: 010183, 010560, 010780, 010951, 010972, 011042, 011050, 011348, 011382, 011583, 011709, 011952, 012343, 012568, 012690, 013071, 013247, 013470, 013692, 013735, 013898, 014125, 014138, 014232, 014312 & 014565 and 9458-VC-006, Lot numbers: 010182, 010436, 010437, 010561, 010562, 010723, 010781, 010782, 010817, 010872, 010893, 010952, 010953, 010964, 010969, 010977, 011039, 011040, 011041, 011060, 011061, 011223, 011378, 011379, 011555, 011556, 011557, 011710, 011711, 011712, 011949, 011950, 011951, 012143, 012144, 012145, 012146, 012344, 012345, 012346, 012460, 012461, 012462, 012575, 012576, 012577, 012691, 012692, 012693, 012897, 012898, 013072, 013086, 013248, 013249, 013250, 013471, 013472, 013473, 013694, 013695, 013696, 013734, 013904, 013905, 013906, 013907, 014116, 014117, 014118, 014119, 014129, 014130, 014131, 014132, 014193, 014194, 014195, 014196, 014313, 014314, 014315, 014402, 014404, 014405, 014406, 014607, 014608 & 014609.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Descripción del producto
    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
  • Manufacturer
  • Modelo / Serial
    Material # 9461-VC-001, Lot numbers: 012579S, 013469S, 011227 & 011492;  Material # 9461-VC-006, 011938, 012694, 013065, 013686 & 014615;  Material # 9462-VC-001, Lot numbers: 010743S, 10778S, 010954S, 012580S & 012891S; Material # 9462-VC-006, Lot numbers: 010444, 010743, 010778, 010954, 011495, 011545, 011582, 011714, 012130, 012581, 013251, 013860, 013893, 014128 & 014316; Material # 9463-VC-001, Lot numbers: 010331S, 010955S, 011716S, 012133S & 013066S; Material # 9463-VC-006, Lot numbers: 010331, 010955, 011513, 011584, 011717, 011834, 012131, 012349, 013070, 013474, 013890, 013899, 014230, 014317 & 014616; Material # 9464-VC-001, Lot numbers: 010445S, 010744S, 010956S, 011718S, 012135S, 012695S & 013262S; Material # 9464-VC-006, Lot numbers: 010445, 010744, 010956, 011051, 011491, 011590, 011719, 011939, 012136, 012350, 012696, 012778, 013252, 013902, 014025, 014120, 014231, 014319, 014453 & 014618; Material # 9465-VC-001, Lot numbers: 010957S, 011940S & 014321S; Material # 9465-VC-006, Lot numbers: 010957, 011496, 011941, 012137, 012351, 013286, 013901 & 014322; Material # 9466-VC-001, Lot numbers: 010333S, 10844S, 010958S, 011722S & 012685S; Material # 9466-VC-006, Lot numbers: 010333, 010844, 010958, 011512, 011544, 011589, 011723, 012129, 012466, 013887, 014123, 014209 & 014323.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Descripción del producto
    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
  • Manufacturer
  • Modelo / Serial
    Material # 9471-VC-006, Lot numbers: 013107, 013260, 013889, 014126 & 014324; Material # 9472-VC-006, Lot numbers: 013108 & 013261; Material # 9403-VC-006, Lot numbers: 010848, 011230, 011587, 012101, 012348, 012697, 013245, 013888, 014127, 014208 & 014407.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Descripción del producto
    ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
  • Manufacturer