FDAFDA · Alimentos y medicamentos·N.º oficial Z-2072-2014
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Publicado el 23 de julio de 2014 · Inicio del retiro: 9 de julio de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Integra LifeSciences Corp.
- Distribuidor
- Algeria, Austria, Belgium, Bulgaria, Cyprus, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Luxemborg, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, Argentina, Brazil, Brunei, Chile, China, India, Japan, Korea, Mexico.
- Lote
- Catog No. 110-4B, Lot No.: 305000222640, 305000223280, 305000223866, 305000223867, 305000224353, 305000225045, 305000225632, 305000225633, 305000226127, 305000226836, 305000226844, 305000227128, 305000228521, 305000228522, 305000228971, 305000229328, 305000229329, 305000229825, 305000229826, 305000230302, 305000230303, 305000230780, 305000230781, 305000231461, 305000231462, 305000232098, 305000232099, 305000232604, 305000232605, 305000233240, 305000233241, 305000233242, 305000233243, 305000233607, 305000233608, 305000234304, 305000235022, 305000236104, 305000236105, 305000236653, 305000236655, 305000237232, 305000238263, 305000238818, 305000238819, 305000242236, 305000243881, 305000243883, 305000243889, 305000244481, 305000244934, 305000245408, 305000245835, 305000246460, 305000247007, 305000247717, 305000248479, 305000249072, 305000249743, 305000250456, 305000251055, 305000251453, 305000252058, 305000252646, 305000254589, 305000255038, 305000257280, 305000257281, 305000258048, 305000258379, 305000258921, 305000258922, 305000259431, 305000259432, 305000259960, 305000259966, 305000260514, 305000261326, 305000261737, 305000262327, 305000262328, 305000262977, 305000263504, 305000263505, 305000264073, 305000264074, 305000264624, 305000265527, 305000265530, 305000266134, 305000266135, 305000266784, 305000267193, 305000267194, 305000267421, 305000268293, 305000268294, 305000268915, 305000269220, 305000269221, 305000270081, 305000271715, 305000271716, 305000272273, 305000272274, 305000272852, 305000273463, 305000273466, 305000274200, 305000274201, 305000274817, 305000275390, 305000275892, 305000276522, 305000277102, 30500R201407, 30500R201421, 30500R202108, 30500X226540, 30500X227059, 30500X227564, 30500X229560, 30500X230565, 30500X231786, 30500X234183, 30500X237761, 30500X238273, 30500X239497, 30500X241368, 30500X246951, 30500X248284, 30500X256614, 30500X259557, 30500X260159, 30500X272367, 30500X274204, 30500Y237087, 3050RX227127, 3050RX241516, 3050RX242793, 3050RX244513, 3050RX253785, 3050RX256709, 3050RX261325, 3050RX264625, 3050RX283314. Calog No. 110-4G, Lot No.: 305000223279, 305000223868, 305000224354, 305000225046, 305000225634, 305000226731, 305000226867, 305000227129, 305000228523, 305000229330, 305000229827, 305000230304, 305000231463, 305000232101, 305000232606, 305000233609, 305000234306, 305000235566, 305000237233, 305000238820, 305000239476, 305000243252, 305000244364, 305000244935, 305000245409, 305000245838, 305000246308, 305000249073, 305000251056, 305000252059, 305000252648, 305000255548, 305000256193, 305000256737, 305000257246, 305000257921, 305000258290, 305000258793, 305000259573, 305000259958, 305000259959, 305000260512, 305000260513, 305000261159, 305000261734, 305000262325, 305000262326, 305000262975, 305000262976, 305000263506, 305000263507, 305000264075, 305000264076, 305000264627, 305000264628, 305000265524, 305000265525, 305000266063, 305000266637, 305000266638, 305000267191, 305000267192, 305000267423, 305000267424, 305000267675, 305000267676, 305000268295, 305000268296, 305000269222, 305000269223, 305000270082, 30500X225383, 30500X226541, 30500X227567, 30500X228784, 30500X229561, 30500X230084, 30500X231054, 30500X231787, 30500X232333, 30500X232776, 30500X233419, 30500X234690, 30500X234807, 30500X236329, 30500X239496, 30500X241357, 30500X242172, 30500X246522, 30500X246873, 30500X247609, 30500X248281, 30500X251061, 30500X251563, 30500X254931, 30500X255143, 30500X259383, 30500X260163, 30500X262443, 30500X263560, 30500X265424, 30500X265978, 30500X266787, 30500X268130, 30500X271048, 30500X275897, 30500Y261771, 3050RX241518, 3050RX242249, 3050RX255039, 3050RX257920, 3050RX258303, 3050RX261160, 3050RX261732, 3050RX266064, 3050RY266786. Catalog No. 110-4H, Lot No.: 305000223622, 305000231714, 305000250959, 305000265974, 30500X225385, 30500X233417, 30500X243874, 30500X254932, 3050RX263557. Catolog No. 110-4L, Lot No.: 305000264077, 305000264175, 305000266062, 305000267297, 305000267784, 305
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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