Device Recall ARROW OnControl

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
  • 제품 설명
    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