BEUDAMED
    FDA Recall Terminated

    Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp

    Recall: Z-3254-2011 · Initiated May 5, 2011

    Recall

    Recall Number
    Z-3254-2011
    Event Number
    59770
    Firm
    Deroyal Industries, Inc. Lafollette
    FEI Number
    3005011024
    Product Code
    HFX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2011
    Posted
    September 16, 2011
    Terminated
    January 30, 2013
    Address
    1501 East Central Ave La, Follette, TN, 37766-2892

    Description

    Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp

    Reason

    The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.

    Action

    DeRoyal Industries, Inc. sent a recall notification letter dated 05/05/2011. A second notice was sent on 07/26/2011 to affected customers who did not respond to the initial notice. Questions regarding this recall may contact the Corporate Attorney at (865) 362-1037.

    Distribution

    USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.

    Quantity

    390 units