Integra Camino Advanced Monitor with Waveform Display
Medical device recall Z-0602-2014. Published in FDA’s Enforcement Report on Jan 8, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 8, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 275 CAM01 Monitors how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
275 CAM01 Monitors, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MEK1200104 MEK1200204 MEK1200304 MEK1200404 MEK1200504 MEK1200604 MEK1200704 MEK1200804 MEK1200904 MEK1201004 MEK1201104 MEK1201204 MEK1201304 MEK1201404 MEK1201504 MEK1201604 MEK1201704 MEK1201804 MEK1201904 MEK1202004 MEL1200104…
Every code shown here, 1,991 characters
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…
FDA’s list runs to 3,024 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 26, 2013.
- FDA classified it on Dec 27, 2013.
- FDA’s Enforcement Report published it on Jan 8, 2014.
- FDA terminated it on Feb 13, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Integra LifeSciences Corp., of Plainsboro, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,024 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.