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Class 2 Device Recall Integra Camino 1104 Intracranial Pressure (ICP) Monitoring |
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Date Initiated by Firm |
July 09, 2014 |
Date Posted |
July 17, 2014 |
Recall Status1 |
Terminated 3 on October 14, 2014 |
Recall Number |
Z-2072-2014 |
Recall Event ID |
68742 |
510(K)Number |
K102875
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Product Classification |
Nystagmograph - Product Code GWN
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Product |
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L |
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 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
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For Additional Information Contact |
Mr. David E. Gronostajski 609-275-0500
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Manufacturer Reason for Recall |
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
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FDA Determined Cause 2 |
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 in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = GWN and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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