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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66243

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 10, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra Limited

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0117-2014
Recall number
Z-0117-2014
Initiated
September 10, 2013
Classification
Class II
Status
Terminated
Recalling firm
Integra Limited
Quantity
79,887

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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.

Distribution pattern

Nationwide Distribution