BEUDAMED
    FDA Enforcement Class II Terminated

    Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

    Recall: Z-1320-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1320-2016
    Event ID
    73497
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    February 29, 2016
    Classification Date
    April 5, 2016
    Termination Date
    March 2, 2018
    Address
    1430 Waukegan Rd, N/A, Mc Gaw Park, IL, 60085-6726, United States

    Description

    Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

    Reason

    Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.

    Code Info

    SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406

    Distribution

    Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.

    Quantity

    SSI-0034: 380 units and 10-1100: 60 units