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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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 Class 2 Recall
Integra
see related information
Date Posted December 27, 2013
Recall Status1 Open
Recall Number Z-0602-2014
Recall Event ID 67094
Premarket Notification
510(K) Number
K962928 
Product Classification Device, Monitoring, Intracranial Pressure - Product Code GWM
Product Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems.
Code Information MEK1200104 MEK1200204 MEK1200304 MEK1200404 MEK1200504 MEK1200604 MEK1200704 MEK1200804 MEK1200904 MEK1201004 MEK1201104 MEK1201204 MEK1201304 MEK1201404 MEK1201504 MEK1201604 MEK1201704 MEK1201804 MEK1201904 MEK1202004 MEL1200104 MEL1200204 MEL1200304 MEL1200404 MEL1200504 MEL1200604 MEL1200704 MEL1200804 MEL1200904 MEL1201004 MEL1201104 MEL1201204 MEL1201304 MEL1201404 MEL1201504 MEL1201604 MEL1201704 MEL1201804 MEL1201904 MEL1202004 MEL1202104 MEL1202204 MEL1202304 MEL1202404 MEL1202504 MEL1202604 MEL1202704 MEL1202804 MEL1202904 MEL1203004 MEL1203104 MEL1203204 MEL1203304 MEL1203404 MEL1203504 MEL1203604 MEL1203704 MEL1203804 MEL1203904 MEL1204004 MEL1204104 MEL1204204 MEL1204304 MEL1204404 MEL1204504 MEL1204604 MEL1204704 MEL1204804 MEL1204904 MEL1205004 MEM1200104 MEM1200204 MEM1200304 MEM1200404 MEM1200504 MEM1200604 MEM1200704 MEM1200804 MEM1200904 MEM1201004 MEM1201104 MEM1201204 MEM1201304 MEM1201404 MEM1201504 MEM1201604 MEM1201704 MEM1201804 MEM1201904 MEM1202004 MEM1202104 MEM1202204 MEM1202304 MEM1202404 MEM1202504 MEM1202604 MEM1202704 MEM1202804 MEM1202904 MEM1203004 MEM1203104 MEM1203204 MEM1203304 MEM1203404 MEM1203504 MEM1203604 MEM1203704 MEM1203804 MEM1203904 MEM1204004 MEA1300104 MEA1300204 MEA1300304 MEA1300404 MEA1300504 MEA1300604 MEA1300704 MEA1300804 MEA1300904 MEA1301004 MEA1301104 MEA1301204 MEA1301304 MEA1301404 MEA1301504 MEA1301604 MEA1301704 MEA1301804 MEC1300104 MEC1300204 MEC1300304 MEC1300404 MEC1300504 MEC1300604 MEC1300704 MEC1300804 MEC1300904 MEC1301004 MEC1301104 MEC1301204 MEC1301404 MEC1301504 MEC1301604 MEC1301704 MEC1301804 MEC1301904 MEC1302004 MED1300104 MED1300204 MED1300304 MED1300404 MED1300504 MED1300604 MED1300704 MED1300804 MED1300904 MED1301004 MED1301104 MED1301204 MED1301304 MED1301404 MED1301504 MED1301604 MED1301704 MED1301804 MED1301904 MED1302004 MEE1300104 MEE1300204 MEE1300304 MEE1300404 MEE1300504 MEE1300604 MEE1300704 MEE1300804 MEE1300904 MEE1301004 MEE1301104 MEE1301204 MEE1301304 MEE1301404 MEE1301504 MEE1301604 MEE1301704 MEE1301804 MEE1301904 MEE1302004 MEE1302104 MEE1302204 MEE1302304 MEE1302404 MEE1302504 MEE1302604 MEE1302704 MEE1302804 MEE1302904 MEE1303004 MEE1303104 MEE1303204 MEF1300104 MEF1300204 MEF1300304 MEF1300404 MEF1300504 MEF1300604 MEF1300704 MEF1300804 MEF1300904 MEF1301104 MEF1301204 MEF1301304 MEF1301404 MEF1301504 MEF1301604 MEF1301704 MEF1301804 MEF1301904 MEF1302004 MEF1302104 MEF1302204 MEF1302304 MEF1302404 MEF1302504 MEF1302604 MEF1302704 MEF1302804 MEF1302904 MEF1303004 MEF1303104 MEF1303204 MEF1303304 MEF1303404 MEF1303504 MEF1303604 MEF1303704 MEF1303804 MEF1303904 MEF1304004 MEF1304104 MEF1304204 MEF1304304 MEF1304404 MEF1304504 MEF1304604 MEF1304704 MEF1304804 MEF1304904 MEF1305004 MEF1305104 MEF1305204 MEF1305304 MEF1305404 MEG1300104 MEG1300204 MEG1300304 MEG1300404 MEG1300504 MEG1300604 MEG1300704 MEG1300804 MEG1300904 MEG1301004 MEG1301304 MEG1301404 MEG1301504 MEG1301604 MEG1301704 MEG1301804 MEG1301904 MEG1302004 MEG1302104 MEG1302204 MEH1300104 MEH1300204 MEH1300304
Recalling Firm/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro, New Jersey 08536-3344
Manufacturer Reason
for Recall
Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.
FDA Determined
Cause 2
DESIGN: Device Design
Action Integra sent an Urgent Medical Device Correction letter and Correction Acknowledgement form dated November 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received one or more of the affected serial numbers that will require this firmware update. Integra asks that you do the following: 1. Review your inventory and verify that you have Camino Advanced Monitors with a serial number formatted as MExxxxxx04. If so, you can continue to use the CAM01 monitor(s), being aware that if you choose to use the optional SYS/DIAS mode, the values on the CAM01 display will be reversed. 2. Complete the attached form. If you do not have the product with the affected serial number in service at your facility, check the box: I do not have any product with a serial number of the form MExxxxxx04. 3. If you do have the affected serial number, check the box: I do have the product with a serial number of the form MExxxxxx04, and please indicate the serial numbers you have. 4. Complete the other information and return it by email or fax as indicated on the form. Complete the form and return it by email or fax as indicated on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
Quantity in Commerce 275 CAM01 Monitors
Distribution Worldwide Distribution - USA ( Nationwide ) and the countries of : UK, Saudi Arabia, South Africa, Brunei, China, France, Poland, Turkey, Greece, Sweden, United Arab Emirates, Russia, Spain, Pakistan, Finland, Israel, Italy, Slovenia, Japan, Poland, Malaysia, Germany and Panama.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = CAMINO NEUROCARE, INC.
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