Device Recall ARROW OnControl

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Société-mère du fabricant (2017)
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • Description du dispositif
    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