BEUDAMED
    FDA Enforcement Class II Terminated

    Hemospray Endoscopic Hemostat

    Recall: Z-2541-2019 · Reported September 25, 2019

    Enforcement

    Recall Number
    Z-2541-2019
    Event ID
    83395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2019
    Initiation Date
    July 24, 2019
    Classification Date
    September 13, 2019
    Termination Date
    June 15, 2020
    Address
    4900 Bethania Station Rd, N/A, Winston Salem, NC, 27105-1203, United States

    Description

    Hemospray Endoscopic Hemostat

    Reason

    Potential for Hemospray device to be unable to spray powder due to misassembly of devices.

    Code Info

    Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224

    Distribution

    Nationwide distribution to CA, CO, CT, FL, IL, IN, KY, LA, MN, MO, NC, NJ, NY, OH, PA, RI, SD, TX, VA, WA. International distribution to Canada, Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain, and United Kingdom.

    Quantity

    160 units