BEUDAMED
    FDA Recall Terminated

    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

    Recall: Z-1134-2014 · Initiated January 16, 2014

    Recall

    Recall Number
    Z-1134-2014
    Event Number
    67442
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    HFX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 16, 2014
    Posted
    March 4, 2014
    Terminated
    October 13, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

    Reason

    Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.

    Action

    DeRoyal initiated the recall by sending overnight letters to its direct accounts on 01/16/2014. If distributors inform DeRoyal of further distribution, DeRoyal will contact those consignees in the same manner. If necessary, further communications will be sent in the form of another mailing, phone calls, and emails to materials management personnel when possible.

    Distribution

    US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.

    Quantity

    2504 units