Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / ...
FDA Device Recall #Z-0117-2014 — Class II — September 10, 2013
Recall Summary
| Recall Number | Z-0117-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 10, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra Limited |
| Location | Plainsboro, NJ |
| Product Type | Devices |
| Quantity | 79,887 |
Product Description
Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. 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. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The 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.
Reason for Recall
Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino¿ Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino¿ Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
Distribution Pattern
Nationwide Distribution
Lot / Code Information
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.
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.