BEUDAMED
    FDA Enforcement Class II Terminated

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    Recall: Z-0137-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0137-2014
    Event ID
    66353
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ITC-Nexus Dx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 13, 2013
    Initiation Date
    August 22, 2013
    Classification Date
    November 4, 2013
    Termination Date
    June 9, 2014
    Address
    23 Nevsky St, N/A, Edison, NJ, 08820-2425, United States

    Description

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    Reason

    ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.

    Code Info

    Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017

    Distribution

    Nationwide Distribution including Arizona andTexas. .

    Quantity

    6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).