Integra LifeSciences Corp.: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L

Recall number

Z-2072-2014

Recalling firm

Integra LifeSciences Corp.

Product

Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L

Status

Terminated

Initiated

2014-07-09

Posted

2014-07-17

Terminated

2014-10-14

Reason

Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.

Root cause

No Marketing Application

Action

A customer notification letter dated 7/9/14 was sent to customers to inform them that Integra LifeSciences has recently revised the labeling of certain Camino Intracranial Pressure Monitoring Kits to indicate they are UNSAFE in an MR environment. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the form attached the letter and return it by email or fax. Customers with questions are instructed to contact Customer Service at (855) 532-1723.

Quantity

28,752 units

Distribution

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.

Lot, serial or model codes

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

510(k) numbers

["K102875"]

PMA numbers

not on file

Product code

GWN

Firm FEI

3003418325

Firm city

Plainsboro

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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