Device Recall IV Start Kits

  • 모델명 / 제조번호(시리얼번호)
    Catalog # : Lot # B7825: 253026-SC, 253046-SC, 253069-SC, 253073-SC, 253081-SC, 253103, 253112, 253120, 253125, 253130, 253144, 253183, 253199, 253216, 253226,  253234, 253245, 253258, 253269, 253281, 253294, 253300, 253301, 253313, 253326, 253341, 253348, 253363. B7837: 233068-SC, 253037-SC, 253041-SC, 253049-SC, 253053-SC, 253057-SC, 253060-SC, 253064-SC, 253074-SC, 253080-SC, 253084-SC, 253087, 253088, 253097, 253100, 253104, 253109, 253113, 253121, 253126, 253133, 253136, 253140, 253146, 253149, 253152, 253159, 253168, 253171,  253177, 253181, 253187, 253188, 253190, 253194, 253196 253198, 253200,  253205, 253207, 253208, 253210, 253214, 253219, 253223, 253227, 253231, 253235, 253238, 253243, 253246, 253251, 253254, 253255, 253257, 253262,  253264, 253272, 253273, 253275, 253278, 253280, 253283, 253288, 253292, 253295, 253299, 253307, 253311, 253315, 253318, 253319, 253324-SC, 253328, 253331, 253336, 253338, 253342, 253350, 253351, 253356, 253358,  253366, 253370, 253372, 253374, 253381, 253384-SC, 253388, 253390, 253392, 253396, 253399, 253401, 253406, 253409, 253411, 253413, 253417, 253421, 253422, 253426, 253432, 253435, 253437, 253439, 253444, 253451, 253452, 253457, 253466, 253470, 253473, 253475, 253476, 253479, 253485, 253491, 253495, 253496, 253500, 253502, 253505, 253512, 253519, 857-SC4. B7841: 233163, 253028-SC, 253033-SC, 253052-SC, 253056-SC, 253065-SC, 253070-SC, 253078-SC, 253091, 253099, 253101, 253106, 253115, 253119, 253124, 253128, 253141, 253147, 253153, 253156, 253169, 253172, 253180, 253191, 253204, 253211, 253222, 253228, 253236, 253242, 253247,  253253, 253261, 253271, 253274, 253279, 253282, 253289, 253297, 253302, 253304, 253308, 253316, 253322, 253327, 253329, 253333, 253339, 253343, 253346, 253352, 253357, 253367, 253369, 253375 800 253379 , 253383-SC, 253391, 253397, 253402, 253410, 253414, 253418, 253420, 253425, 253430, 253438, 253440, 253453, 253455, 253458, 253468, 253469, 253477, 253480, 253486, 253492, 253504, 253506, 253511, 253515,  253521, 253530. B7842: 20600, 253036-SC, 253040-SC, 253062-SC, 253079-SC, 253107, 253116, 253142, 253157, 253166, 253175, 253192, 253195, 253212, 253224, 253240, 253249, 253276, 253286, 253305, 253320, 253332, 253344, 253364, 253376, 253380, 253385, 253407, 253415, 253423, 253436, 253441, 253459, 253462, 253481, 253487, 253493, 253503, 253535. B7844: 253047-SC. B7846: 253513. B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2098782, 2145226, 253009-SC, 253035-SC, 253066-SC, 253089, 253123, 253139, 253160, 253178, 253197, 253213, 253241, 253265, 253285, 253303,, 253310, 253325, 253337, 253360, 253386, 253403, 253405, 253427, 253449, 253463, 857-SC1. B7928: 213167, 233061-SC, 253045-SC, 253055-SC, 253059-SC, 253077-SC, 253082-SC, 253086, 253093, 253095, 253102, 253111, 253118, 253129, 253137, 253145, 253151, 253158, 253173, 253176, 253186, 253193, 253201,  253206, 253209, 253218, 253220, 253230, 253232, 253239, 253248, 253252, 253256, 253260, 253268, 253277, 253287, 253291, 253296, 253306, 253312,  253317, 253323, 253330, 253334, 253340, 253345, 253349, 253353, 253359,  253368, 253371, 253382, 253389, 253393, 253398, 253404253408, 253416, 253424, 253429, 253433, 253442, 253448, 253454, 253460, 253464, 253471,  253478, 253483, 253488, 253494, 253497, 253501, 253507. B7932: 2010961, 2012567, 2012965, 2022800.  B7937: 253355, 253362, 253377, 253394.  B7938: 253354, 253361, 253378, 253395.  Z0125: 78-458-YJ.  Z8015: 59-941-SN, 61-164-LA, 61-898-LA, 62-799-R5, 63-307-YJ, 64-027-2A, 64-245-K4, 65-616-K4, 66-136-R5, 67-582-YJ, 67-803-2A, 69-758-R5, 70-155-K4, 71-538-LA, 73-027-YJ, 73-736-YJ, 74-402-K4, 74-962-R5, 76-203-2A, 77-360-R5, 80-869-R5, 80-957-K4, 85-657-LA, 88-569-2A, 89-613-SN, 92-782-R5, 94-196.2A, 94-196-2A  Z8017: 61-577-K4, 63-347-SN, 64-194-2A, 64-407-K4, 68-446-K4, 70-351-2A, 72-636-YJ, 73-735-YJ, 74-585-K4, 78-846-2A, 81-540-2A, 84-591-YJ, 86-016-SN, 89-540-LA, 91-210-LA, 92-295-YJ, 92-781-R5, 93-166-LA.  Z8028: 57-112-R5, 58-440-LA, 62-236-R5, 62-239-R5, 63-308-YJ, 64-028-2A, 65-333-LA, 65-617-K4, 66-352-R5.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries of: Austria, Belgium, Chile, Cyprus, CZ, France, Germany, Great Britain, Greece, Israel, Italy, Lithuania, Netherland, Poland, Russia, Saudi Arabia, Sweden, and Switzerland.
  • 제품 설명
    IV Start Kits || Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673
  • 제조사 모회사 (2017)
  • Source
    USFDA