Device product
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Z-2072-2014
Product summary
- Event
- Event 68742
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,752 units
- Official record key
device-enforcement:Z-2072-2014
Official wording
Reason: Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
Code information: 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, 305000268412, 305000268916, 305000271872, 305000272591, 305000275481, 30500X266522, 30500X272374, 30500X274963, 3050RX259553, 3050RX260626, 3050RX265531, 3050RY266146
Distribution pattern: 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.
Derived failure modes
-
Unknown
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.