Retiro De Equipo (Recall) de Device Recall Arrow 4 way HiFlo Stopcock with male luer lock latex free

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Arrow International Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    IV accessory - Product Code FPA
  • Causa
    Leakage: material not lipid resistant, may crack and/or leak. use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
  • Acción
    Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.


  • Modelo / Serial
    All lots of Product codes: AA-00605, AA-00611, AA-00624, AA-15511, AA-15511-S, AA-15611, AA-15611-S, AA-15624, AD-04700, AD-04730, AD-09903, AD-09903-S, AD-12802, AD-12802-GH, AD-14702-EK, AD-14703, AD-14854, AD-15703, AD-16702, AD-24703, AD-24703-OB, AD-24730-OB, AD-24730-OL, AD-24802, AD-24854, AD-24854-NL, AD-25703, AD-25802-OB, AD-25855, AD-26702, AH-09801, AI-06210-IK, AI-06210-KS, AI-07155-IK, AI-07155-KS, AJ-01671, AJ-09801, AJ-09886, AJ-09903, AJ-17702-J, AK-04306-EB, AK-07801, AK-07803-AG, AK-07903, AK-09802, AK-09802-A, AK-09803, AK-09803-CDC, AK-09803-LF, AK-09803-LFSP, AK-09804, AK-09804-AG, AK-09807, AK-09807-AG, AK-09810, AK-09810-C, AK-09810-S, AK-09813-T, AK-09817-S, AK-09883-S, AK-09903-AG, AK-09903-CDC, AK-09903-J, AK-09903-JJ, AK-09903-LFSP, AK-09907-S, AK-09908-S, AK-12702-J, AK-12703-EB, AK-12703-TL, AK-14703-J, AK-15703-J, AK-15802-J, AK-15854-LA, AK-16702-J, AK-17702-J, AK-17752-J, AK-17753-J, AK-24301-J, AK-24703-J, AK-26702-J, AK-27702-J, AK-29803-CDC, AK-29903-CDC, AK-29907-CDC, AM-15703-J, AMPHIA-25703, AMPHIA-25855, ASK-01651-TRC, ASK-04301-KR, ASK-04701-KR, ASK-09800-HCA, ASK-09800-HCA1, ASK-09803-BMH, ASK-09803-PHC, ASK-09803-WBH, ASK-09810-PCMH, ASK-09817-MM, ASK-09883-UPM, ASK-09903-BMH, ASK-09903-DHM, ASK-09903-ECL, ASK-09903-ECLH, ASK-09903-HUP, ASK-09903-MGH, ASK-09903-NM, ASK-09903-PCMH, ASK-09903-PMH, ASK-09903-PMH1, ASK-09903-SB, ASK-09903-UR, ASK-09903-YNH, ASK-09907-SL, ASK-09907-SP, ASK-09907-SP1, ASK-11142-MGH1, ASK-14702-KR, ASK-14703-KR, ASK-15703-KR, ASK-17702-KR, ASK-17752-KR, ASK-18763-KR, ASK-29803-HF, ASK-29803-HF1, ASK-29803-SJH, ASK-29903-OHU, ASK-29903-UW, ASK-29903-UW1, ASK-42703-ECL, ASK-42703-ECLH, ASK-42802-ECL, ASK-42802-ECLH, ASK-45703-ECL, ASK-45703-ECLH, ASK-45854-ECL, ASK-45854-ECLH, BB-04706-C, BB-09903-AG, BB-12853, BB-22122-F, BB-22123-F, BK-22703, BL-22702, BL-22703, BP-09805, BR-10703, BR-10854, BR-12703, BR-12703-UK, BR-12853, BR-12853-E, BR-12854, BR-14853-EK, BR-15703, BR-15703-UK, BR-15853, BR-15853-E, BR-15853-SA, BR-15854, BR-22703, BR-22853, BR-22854, BR-25703, BR-25854, BR-99703, BU-25703-E, CA-09801, CA-09803, CA-09807, CA-09886, CA-09903-LF, CA-09903-S, CA-11142, CA-11142-A, CB-04730-EK, CB-25703, CB-99854, CDC-09803-1A, CDC-09903-1A, CDC-29803-1A, CDC-29903-1A, CH-09903-S, CK-01000, CK-01409, CL-07011, CL-07024, CL-07035, CL-07045, CL-07065, CL-07080, CL-07511, CL-07524, CL-07545, CL-07565, CL-07590, CL-07611, CL-07624, CL-07635, CL-07645, CL-07665, CL-07690, CL-07700, CL-07711, CL-07724, CL-07724-TB, CL-07735, CL-07745, CL-07765, CL-07780, CL-07790-R, CL-07800, CL-07811, CL-07824, CL-07835, CL-07845, CL-07865, CL-07880, CL-07900, CL-07911, CL-07924, CL-07965, CL-07980, CL-08403, CL-08403-A, CL-08503, CL-08503-A, CL-08505, CL-08603, CL-08605, CL-08605-HF, CL-08703, CL-08705-HF, CL-08803, CL-08903, CL-71165, CL-71180, CO-04730-EK, CO-14702-EK, CO-14703-EK, COE-04730-EK, COE-14702-EK, COE-14703-EK, CP-07011, CP-07511, CP-07511-P, CP-07611, CP-07611-P, CP-07711, CP-07811, CP-07911, CP-08403, CP-08503, CP-08503-A, CP-08603, CP-08603-P, CP-08703, CP-08803, CP-08903, CR-07645, CR-07745, CR-07745-NT, CS-14703-S, CS-15703-S, CS-16702-S, CS-17702-S, CS-18763-E, CS-25703-GRE, CS-25802-GRE, CT-07860, CW-08403, CW-08503, CW-08503-A, CW-08603, CW-08703, CW-08803, CW-08903, DA-04701, DA-15703, DA-15854, DG-09810-AG, DK-24702-EK, DK-24703-EK, DK-24730-EK, DM-09306, DM-09903-EB, DU-12703, DU-22703, DU-24706, DU-25142-F, EN-24702, EN-24730, ES-14702-D, ES-14854-D, EU-24702-EK, EU-24703-EK, EU-24730-EK, FL-09908-S, FO-25000, GS-09803, GU-24703, GU-24854, HA-24730-EK, HE-04730, HE-14703, HH-01000-D, HH-09803, HL-09883, HP-09903, HS-04401, HS-14853, IB-17752, IB-18763, IC-09880, IK-09600, JD-25703, KC-04701-J, KD-25703, KF-24730, KM-09886-J, LA-01000, LS-15853, LS-17702, LU-09803-S, LU-09903, MA-04301, MA-12123, MA-14703, MA-15703, MA-15855, MH-04701-C, MH-09810-VKS, MH-14703-C, MO-12123-F, MPI-17191, MPI-17326, MPI-17552, MPI-17894, MPI-17895, MPI-17895, MPI-17897, MPI-17898, MPI-17899, MPI-17900, MPI-17927, MPI-17948, MPI-18054, MS-07803, MS-07803-AG, MS-07903-AG, MS-09600, MS-22123-E, MS-24703-EK, MS-24730-EK, MS-24854-EK, MSO-01409-JHH, MSO-09801-ANW, MSO-09903-PH, MSO-11142-NMH(14), MTO-04701-KR, MTO-09801-CHA, MTO-09903-BMH, MTO-09903-UPA, MTO-09903-WHS, MTO-09907-SL, MTO-14703-OPH, MTO-15703-TCH, MTO-17702-J, MTO-17702-KR, MTO-17702-TCH, MTO-17752-J, MTO-18702-OM, MZ-09883-S, NH-09803-B, NL-09903-S, NM-07903, NM-09803-LF, NM-12853, NR-09810-S, NR-09903-S, NS-09803, NY-09903-S, OC-17702-J, OF-25703, OF-25802, OF-25854, OF-25855, OR-17702-J, OU-04301-J, OU-15703-J, OU-15703-J, OU-17702-J, OU-17702-J, OU-17752-J, OU-17752-J, PAVIA-22703, PB-09803, PB-09903, PC-09903-S, PH-09806, PM-09903-K, PM-27702, PS-09810-S, PT-12709-WC, PT-45509, PT-65509-HFC, PT-65709-WC, RB-15703, RO-15703, RO-25703, RO-25703-E, RV-09803, SA-09854, SB-09803, SB-09883-S, SB-09903-S, SB-09907-S, SC-00001, SE-09810-S, SE-15854-L, SF-09801, SG-09903, SH-17702-J, SH-17752-J, SI-09600-LJ, SI-09700-LJ, SI-09808-J, SI-09808-LJ, SI-09880-AGLJ, SI-09880-J, SI-11142, SI-11242, SJ-09883-S, SL-09807, SL-24701, SL-25853, SL-25855, SM-09802, SM-09813-T, SM-09903-S, SP-09801, SU-09903-C, SU-09903-S, SV-09804, TR-09880-C, UC-09880-S, UD-12123, UE-09800, UE-22123-F, UE-24702-ND, UE-24703-ND, UE-24730-ND, UE-25000-UC, UE-25703-FS, UE-25854-FS, UE-25855-ND, UF-14702, UF-14703, UF-22123-F, UF-24703, UF-24854, UF-25703, UF-25854, UF-25855, UF-26702, UG-14703-C, UH-15853, UK-14703-C, UK-24703, US-04730-EK, VG-09813, VI-15703, W01271, W01272, W15500, W15549, W15567, W15593, W19910, W19922, W19945, W19959, W19962, W19980, W20027, W20041, W20042, W20046, W20050, W20056, W20058, W20058-BNS, W20060, W20074, W20077, W20111, W20123, W20124, W20135, W20139, W20154, W20166, W20168, W20171, W20173, W20175, W20178, W20182, W20185, W20196, W20211, W20214, W20216, W20224, W20225, W20228, W20233, W20239, W20249, W20253, W20267, W20290, W20302, W20317, W20319, W20322, W20339, W20346, W20363, W20365, W20366, W20375, W20379, W20384, W20403, W20407, W20414, W20415, W20425, W20430, W20451, W20469, W20477, W20480, W20481, W20483, W20487, W20488, W20489, W20497, W20503, W20515, W20518, W20525, W20530, W20541, W20546, W20553, W20595, W20597, W20615, W20617, W20626, W20627, W20640, W20656, W20663, W20670, W20674, W20675, W20678, W20684, W20697, W20710, W20723, W20724, W20735, W20736, W20737, W20739, W20743, W20745, W20753, W20770, W20778, W20782, W20783, W20787, W20788, W20790, W20813, W20817, W20819, W20828, W20845, W20857, W20859, W20867, W20880, W20881, W20884, W20886, W20896, W20911, W20920, W20921, W20949, W20954, W20975, W20995, W20998, W21001, W21006, W21013, W21022, W21026, W21035, W21036, W21041, W21043, W21064, W21065, W21073, W21074, W21087, W21091, W21093, W21096, W21109, W21111, W21114, W21119, W21120, W21126, W21131, W21136, W21137, W21141, W21148, W21158, W21159, W21177, W21178, W21180, W21191, W21202, W21206, W21230, W21232, W21253, W21259, W21270, W21288, W21301, W21305, W21310, W21320, W21323, W21339, W21344, W21345, W21354, W21356, W21359, W21365, W21372, W21383, W21388, W21395, W21399, W21413, W21425, W21439, W21441, W21443, W21447, W21448, W21450, W21463, W21464, W21465, W21470, W21472, W21492, W21493, W21499, W21503, W21507, W21509, W21510, W21511, W21514, W21517, W21520, W21537, W21547, W21556, W21558, W21559, W21560, W21565, W21570, W21582, W21592, W21597, W21601, W21603, W21608, W21609, W21610, W21612, W21615, W21635, W21638, W21652, W21654, W21657, W21659, W21668, W21683, W21692, W21703, W21704, W21715, W21716, W21723, W21731, W21738, W21739, W21742, W21748, W21749, W21756, W21765, W21770, W21772, W21773, W21779, W21780, W21781, W21783, W21789, W21794, W21800, W21823, W21824, W21836, W21837, W21842, W21863, W21864, W21870, W21873, W21882, W21891, W21894, W21902, W21913, W21914, W21915, W21917, W21922, W21925, W21926, W21931, W21935, W21939, W21948, W21950, W21954, W21960, W21961-DF, W21967, W21969, W21972, W21973-DF, W21983, W21984, W21985, W21987, W21989, W21997, W22003, W22004, W22012, W22021, W22042, W22045, W22046, W22049, W22051, W22052, W22060, W22061, W22065, W22073, W22074, W22077, W22095, W22101, W22102, W22104, W22106-DF, W22108, W22113, W22121, W22138, W22140, W22141, W22149, W22151, W22155, W22156, W22158, W22167, W22174, W22185, W22186, W22188, W22192, W22196, W22214, W22218, W22219, W22220, W22227, W22232, W22233, W22237, W22238, W22239, W22240, W22241, W22242, W22243, W22245, W22247, W22248, W22249, W22250, W22254, W22255, W22256, W22266, W22268, W22269, W22271, W22272, W22280, W22281, W22285, W22295, W22306, W22315, W22317, W22318, W22322, W22325, W22329, W22335, W22337, W22339, W22342, W22344, W22345, W22346, W22347, W22350, W22351, W22352, W22353, W22354, W22355, W22357, W22358, W22360, W22361, W22363, W22366, W22367, W22371, W22374, W22378, W22382, W22383, W22384, W22391, W22394, W22396, W22397, W22398, W22399, W22402, W22403, W22405, W22407, W22408, W22413, W22416, W22417, W22420, W22429, W22433, W22437, W22440, WR-24703, YN-09903-S, ZW-27702-J
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
  • Descripción del producto
    Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits.
  • Manufacturer


  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Empresa matriz del fabricante (2017)
  • Source