BEUDAMED
    FDA Recall Terminated

    LICOX temperature probe, Model C8.B

    Recall: Z-0623-05 · Initiated January 21, 2005

    Recall

    Recall Number
    Z-0623-05
    Event Number
    31117
    Firm
    Integra Neuro Sciences
    FEI Number
    2023988
    Product Code
    GMW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 21, 2005
    Posted
    March 15, 2005
    Terminated
    July 13, 2005
    Address
    5955 Pacific Center Blvd, San Diego, CA, 92121-4309

    Description

    LICOX temperature probe, Model C8.B

    Reason

    LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

    Action

    LICOX Model C8.B temperature probes and LICOX IM3.ST Complete Brain IMC Probe Kits manufactured by GMS mbH, an Integra company, may exhibit pyrogen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

    Distribution

    LA, CA, CO, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, NE, NY, OH, OR, PA, SD, TN, TX, VA

    Quantity

    19