{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121831", "product_res_number": "Z-0117-2014", "event_date_initiated": "2013-09-10", "event_date_posted": "2013-10-30", "recall_status": "Terminated", "event_date_terminated": "2014-06-04", "res_event_number": "66243", "product_code": "GWM", "k_numbers": [ "K102875" ], "product_description": "Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring\nCatheters.\nProduct / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.\nThe fully packaged 110-4B, 110-4H, and 110-4L catheters are\nalso provided as a component in kits that contain other cranial\naccess devices. These kits are Catalogue No. 110-4BC, 110-\n4HC, and 110-4LC respectively.\n\nCommon Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits\nClassification Name: Device, Monitoring, Intracranial Pressure\n510(k) Number: K102875\n\nThe Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.", "code_info": "Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.  Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000233245, 305000233244, 305000233243, 305000233242, 305000233241, 305000233240, 30500X233415, 30500X234183, 305000233607, 305000233608, 30500X234806, 305000234303, 305000234304, 305000235022, 305000235017, 30500X235732, 305000235598, 30500X236328, 305000236105, 305000236104, 305000236655, 305000236653, 30500Y237087, 30500X237090, 305000237232, 30500X237761, 305000237824, 305000237825, 30500X238273, 305000238263, 305000238264, 30500X239095, 305000238818, 305000238819, 30500X239497, 30500X239748, 30500X239958, 30500X240334, 30500X240668, 30500X241368, 305000241516, 305000242236, 305000242792, 305000242795, 305000242796, 305000242794, 305000242793, 305000242791, 3050RY243869, 305000243251, 305000243882, 305000243881, 305000243888, 305000243889, 305000243883, 30500X244281, 30500X244880, 305000244513,30500X245306, 305000244481, 305000244480, 305000244934, 30500X245937, 30500X246067, 305000245408, 30500X246872, 305000245835, 30500X246951, 30500X247608, 305000246460, 30500X248284, 305000247007, 3050RX227127, 3050RX234303, 305000247717, 305000249072, 3050RX242794, 3050RX242793, 3050RX237825, 3050RX241516, 30500X249488, 305000248479, 30500X250423, 305000249743, 30500X250964, 305000250456, 30500X251060, 305000251055, 30500X251560, 30500X252133, 3050RY252136, 305000251453, 30500X252771, 305000252058, 3050RX244513, 305000252646, 305000253785, 30500X254929, 3050RY255145, 30500X255141, 305000254589, 305000255549, 305000255551, 305000255038, 30500X256614, 305000256192, 305000257281, 305000256709, 305000257280, 305000258048, 30500X259385, 305000258379, 305000258921, 305000258922, 30500X259557, 305000259431, 305000259432, 30500X260159, 305000259966, 305000259960, 305000260514, 305000260527, 30500Y261748, 3050RX253785, 305000261325, 305000261326, 305000261737, 305000261736, 3050RX256192, 30500X262441, 305000262328, 305000262327, 305000262978, 305000262977, 3050RY263508, 30500X263559, 305000263504, 305000264073, 305000264074, 305000264625, 305000264624, 3050RY265348, 30500X265422, 30500X265976, 3050RY265975, 305000265530, 305000265527, 30500X266142, 305000266134, 305000266135, 30500X266789, 305000267193, 305000267194, 3050RX261325, 30500X267468, 305000267421, 305000267422, 30500X267990, 305000267673, 305000267674, 305000268294, 305000268293, 305000266784, 305000268914, 305000268915, 3050RX261736, 3050RY269955, 30500X269963, 305000269220, 305000269221, 305000270081, 3050RY271045, 30500X271047, 305000271042, 305000271716, 305000271715, 30500X272367, 305000272273, 305000272274, 305000272852, 305000272851, 30500X274204, 305000273466, 305000273463, 305000274200, 305000274201, 30500X275297, 30500X275393, 305000274816, 30500X276594, 3050RX268914, 305000277761, 3050RY282196, 305000282304, 30500X282815, 3050RY283371, 3050RX283315, 3050RX283314    Catalog Number 110-4G: 3050RX195650, 3050RX198690, 3050RY193969, 3050RY197837, 3050RX199151, 3050RX199942, 3050RX201552, 3050RY185259, 3050RX200538, 305000206177, 3050RX200989, 305000206556, 305000206557, 3050RX200990, 3050RY199151, 3050RY199942, 305000207465, 3050RY200538, 3050RY200989, 305000208007, 3050RY200990, 3050RX207465, 3050RX206557, 3050RX206556, 305000209417, 305000209105, 3050RX208007, 305000210891, 305000211419, 3050RX206177, 30500X209105, 3050RX209417, 305000212298, 30500X210891, 305000213240, 305000214103, 30500X215501, 30500X215577, 3050RX202201, 305000215628, 3050RY195650, 3050RY198690, 30500X216621, 305000216246,3050RY217113, 30500X217118, 305000217140, 30500X217835, 3050RY217839, 305000217464, 30500X218393, 305000218009, 30500X219053, 305000218225, 305000219118, 30500X220001, 30500X220429, 305000219990, 30500X221225, 305000221227, 30500X222567, 305000222642, 305000223279, 30500X223707, 305000223868, 30500X224685, 305000224354, 30500X225383, 305000225046, 305000225634, 30500X226000, 30500X226541, 305000226731, 305000226869, 305000226867, 30500X227567, 305000227129, 30500X228784, 305000228523, 305000228973, 30500X229561, 305000229330, 30500X230084, 305000229827, 305000230304, 30500X231054,305000230782, 30500X231787, 305000231463, 30500X232333, 305000232101, 30500X232776, 305000232606, 30500X233419, 305000233246, 305000233609, 30500X234690, 30500X234807, 305000234306, 305000235566, 30500X236329, 30500Y237088, 30500X237767, 305000237233, 305000238820, 30500X239496, 305000239476, 30500X240336, 30500X241357, 305000241518, 30500X242172, 305000242249, 305000243252, 305000244364, 30500X245304, 305000244935, 305000245409, 305000245838, 30500X246522, 305000246308, 30500X246873, 30500X247609, 30500X248281, 305000249073, 3050RX241518, 3050RX233246, 3050RX242249, 3050RX228973, 30500X251061, 305000251056, 30500X251563, 3050RY252137, 305000252059, 305000252648, 305000254591, 30500X254931, 30500X255143, 305000255039, 305000255548, 305000256193, 305000256737, 305000257244, 305000257246, 305000257921, 305000257920, 305000258303, 305000258290, 30500X259383, 305000258793, 305000259573, 30500X260163, 305000259958, 305000259959, 3050RX254591, 3050RX255039, 305000260513, 305000260512, 30500Y261771, 3050RX257244, 3050RX257920, 305000261159, 305000261160, 3050RY262444, 30500X262443, 305000261734, 305000261732, 305000262325, 305000262326, 3050RX258303, 305000262976, 305000262975, 3050RY263510, 30500X263560, 305000263507, 305000263506, 305000264075, 305000264076, 305000264627, 305000264628, 30500X265424, 305000265525, 305000265524, 30500X265978, 30500X266143, 305000266063, 305000266064, 30500X266787, 305000266638, 305000266637, 305000267191, 30500X267470, 305000267423, 305000267675, 3050RY269957, 30500X274206  Catalog Number 110-4H: 3050RX198281, 3050RY194144, 3050RY198281, 3050RY200861, 30500X223154, 305000220948, 305000223622, 30500X225385, 30500X233417, 305000231714, 305000241350, 30500X243874, 305000250959, 30500X254932, 305000263557  Catalog Number 110-4L: 305000221383, 30500X222566, 305000222762, 30500X223971,305000223969, 305000225078, 30500X226539, 305000226221, 30500X227058, 305000226848, 305000226749, 305000226847, 305000226871, 305000226,870, 30500X228783, 305000229450, 305000229909, 305000230871 30500X232775, 305000232199, 30500X232961, 305000233311, 305000234438, 30500X235731, 305000235181, 305000236201, 305000237368, 305000237369, 305000237799, 305000238539, 305000239102, 30500X240245, 30500X240246, 30500X240247, 305000239736, 305000239737, 30500X241365, 30500X241522, 305000241082, 30500X242170, 30500X245765, 30500X246521, 3050RX237799, 3050RX226749, 3050RX229450, 3050RX241082, 3050RX232199, 3050RY252775, 3050RX240446, 3050RY255148, 305000259553, 305000260626, 305000261835, 305000262436, 3050RX259553, 305000263146, 3050RX260626, 305000264077, 3050RX262436, 3050RX261835, 305000264175, 3050RY265351, 3050RY265766, 305000265531, 30500X266144, 3050RY266146, 30500X266522, 305000266062, 305000267297, 30500X267473, 30500X268133, 305000267784, 305000268412, 3050RX265531, 305000268916, 3050RY271046, 305000271872, 30500X272374, 305000272591, 30500X274210, 30500X274963, 305000281820   Catalog Number 110-4BC: 176044, 177018, 178013, 178898, 179757, 180139, 180955, 182279, 182908, 184079, 184687, 185284, 186277, 187293, 190452, 187780, 190451, 191891, 193414, 194074, 195161, 195608, 196987, 197492, 198189, 198512, 200069, 200490, 199609, 201039, 201595, 202423, 203565, 207077, 208532  Catalog Number 110-4HC: 179758, 180956, 183071, 184686, 186278, 187781, 190450, 192246, 194993, 195450, 198191, 199708, 201040, 201596, 202009   Catalog Number 110-4LC: 162523, 167450, 167786, 175720, 177188, 178547, 182130, 187495, 195245, 197493.", "firm_fei_number": "3001700044", "recalling_firm": "Integra Limited", "address_1": "311 Enterprise Dr", "city": "Plainsboro", "state": "NJ", "postal_code": "08536-3344", "reason_for_recall": "Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA\nrequirements, certain Camino Intracranial Pressure Monitoring Kits require additional labelling to indicate\nthey are UNSAFE in an MR environment.\nOnly the following Camino Intracranial Pressure Monitoring Kits are affected:\n110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.", "root_cause_description": "Under Investigation by firm", "action": "Integra sent an Urgent Medical Device Correction Field Safety Notice dted September 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and determine if they have any of the affected product. If so, customers were asked to ensure that the information contained in the letter be distributed to the appropriate personnel. Complete the attached form return it by email or fax as indicated on the form. Customers with questions were instructed to contact Customer Service at 1-855-532-1723.\nFor questions regarding this recall call 1-800-997-4868, outside of the US 888-980-7742.", "product_quantity": "79,887", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K013930", "K802100", "K801755", "K201989", "K141869", "K121573", "K120252", "K862012", "K013705", "K053244", "K912139", "K992591", "K940648", "K962928", "K983799", "K071505", "K200630", "K022638", "K840999", "K981846", "K853864", "K772063", "K002392", "K020780", "K883115", "K041838", "K061640", "K914479", "K840003", "K173192", "K130529", "K822636", "K802149", "K863479", "K890468", "K980380", "K133754", "K974088", "K102875", "K930221", "K152670", "K881183", "K914735", "K844566", "K854657", "K882552", "K802138", "K040235", "K101133", "K862820", "K883881", "K884823", "K010422", "K022553", "K883518", "K931609", "K172209", "K201118", "K183406", "K072379", "K790920", "K853770", "K050702", "K071984", "K020285", "K232890", "K102077", "K250285", "K945585", "K161010", "K882286", "K002765", "K171666", "K083378", "K020558", "K802137", "K113088", "K200456", "K051599", "K982702", "K121159", "K822864", "K003759", "K112017", "K880154", "K131184", "K062584", "K252241", "K943987", "K210993", "K032337", "K991222", "K031086", "K162108", "K103206", "K042728", "K182073", "K050720", "K060554", "K240821", "K896834", "K003905", "K153347", "K893395", "K813440" ], "registration_number": [ "3003730855", "2029275", "3001587388", "3023852420", "1220477", "3012507533", "3009865268", "3006240422", "3008102042", "3042902796", "3018094310", "1836324", "3043513133", "3004070722", "2011171", "3044156918", "3002108226", "3013944123", "3006942548", "3002808022", "9612501", "3011689956", "3015151147", "9616567", "3003851947", "9611274", "3005067367", "3014255018", "2916714", "1721983", "1526863", "9617601", "3002807315", "3017180827", "2024024", "2032112", "3023540124", "2953359", "3010611950", "3013886523", "2030624", "3007156625", "3012266672", "3014334038", "3003733874", "3024673", "2183744", "3017636737", "8010468", "3013557562", "3007029079", "3015531529", "3027605168", "3004114361", "3007603826", "2023988", "3008114965", "3006697299", "3004593495", "3008791915", "3023074935", "3009171251", "3003418325", "3010948104", "3004920696", "3006946348", "3028006458" ], "fei_number": [ "3003730855", "3001587388", "3002534070", "3023852420", "1220477", "3003076831", "3012507533", "3009865268", "3003495548", "3042902796", "3018094310", "3043513133", "3004070722", "2011171", "3044156918", "3002108226", "3013944123", "3006942548", "3002808022", "3011689956", "3015151147", "3003851947", "3002924544", "2916714", "3014255018", "1625382", "1526863", "3002807315", "3017180827", "2024024", "3023540124", "1000064530", "1000306431", "3010611950", "3013886523", "3002998595", "3006759904", "3012266672", "3014334038", "3003733874", "3024673", "2183744", "3017636737", "3546", "3013557562", "3002806577", "3002963732", "3015531529", "3007029079", "3004114361", "3000215205", "3007603826", "2023988", "3008114965", "3006697299", "3004593495", "3008791915", "3023074935", "3006946348", "3003418325", "3010948104", "3004920696", "3002808043", "3008133910", "3000206435", "3028006458" ], "device_name": "Device, Monitoring, Intracranial Pressure", "medical_specialty_description": "Neurology", "regulation_number": "882.1620", "device_class": "2" } } ] }