BEUDAMED
    FDA Recall Terminated

    Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; DeRoyal C-SECTION TRAY, REF 89-5256.06 Lot Number: 26185242; DeRoyal C V MINOR TRAY, REF 89-5277.02 Lot Number: 25793211; DeRoyal COMBINED EXTREMITY PACK, REF 89-6773.02 Lot Numbers: 25744022, 26010670, 26194641; DeRoyal DISKECTOMY TRAY, REF 89-6196.03 Lot Number: 26097373; DeRoyal MAJOR DRAPE PACK, REF 89-7255.01 Lot Number: 26011736; DeRoyal EXTREMITY PACK PGYBK, REF 89-5275.05 Lot Number: 26063270; DeRoyal SCOPE SHOULDER TRAY, REF 89-5653.03 Lot Number: 26227422; DeRoyal KNEE SCOPE PACK, REF 89-5654.03 Lot Number: 26020510; DeRoyal BILATERAL DRAPE, REF 89-5379.02 Lot Number: 26042735, 26282421; DeRoyal LAPAROSCOPIC CHOLE PACK, REF 89-5259.05 Lot Number: 25817201; DeRoyal MAJOR HIP PACK, REF 89-4718.04 Lot Number: 25840313; DeRoyal SPINE PACK, REF 89-4150.06 Lot Number: 25933077; DeRoyal ARTHROSCOPY TRAY, REF 89-5317.02 Lot Number: 26078463; DeRoyal LARGE VASCULAR TRAY, Lot Number: 26078447; DeRoyal SMALL VASCULAR TRAY, REF 89-3694.13 Lot Number: 261449399; DeRoyal ASC VASCULAR PACK PGYBK, REF 89-6284.05 Lot Number: 25698986; DeRoyal ASC BREAST PACK, REF 89-6285.06, Lot Number: 26078578; DeRoyal ASC FOOT/ANKLE PACK, REF 89-6014.07 Lot Numbers: 26096856, 26147916; DeRoyal ACUTE BURN EXCISION TRAY, REF 89-3330.05 Lot Number: 26078367; DeRoyal RECONSTRUCTION TRAY, REF 89-3331.04 Lot Numbers: 25817383, 26019720; DeRoyal FOOT PACK, REF 89-6467.05 Lot Number: 25880438; DeRoyal TRAUMA PACK, REF 89-6776.04 Lot Number: 26010688; DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5257.08 Lot Numbers: 26125434, 26149102; DeRoyal CHILDRENs ORTHOPEDIC TRAY, REF 89-3479.08 Lot Numbers: 25873676, 25905092 DeRoyal KNEE SCOPE, REF 89-2910.09 Lot Number: 25695611; DeRoyal SPINE PACK PGYBK, REF 89-6720.01 Lot Number: 26022048; DeRoyal OPEN SHOULDER PROCEDURE PACK, REF 89-6629.01 Lot Number: 25839187; DeRoyal ORTHO TOTAL BASIC TRAY, REF 89-2650.15 Lot Numbers: 25893423, 26010207, 26077111; DeRoyal ORTHO TOTAL HIP/KNEE TRAY, REF 89-2644.17 A & B Lot Number: 25894012; DeRoyal MINOR/PLASTIC PACK, REF 89-6994.02 Lot Number: 25853544; DeRoyal OPEN HEART PACK, REF 89-6996.02 Lot Number: 25853608; DeRoyal GEN SURG UNIV PACK, REF 89-6991.02 Lot Number: 25696032; DeRoyal PERI VASCULAR PACK, REF 89-6998.03 Lot Number: 25853587; DeRoyal VASCULAR PACK, REF 50-4157.29 Lot Number: 25732507; DeRoyal OPEN HEART B, REF 50-13010.19 Lot Number: 26009978; DeRoyal GENERAL ORTHO PACK, REF 89-6883.02 Lot Number: 25695911; DeRoyal HIP COUNTABLES TRAY, REF 89-5382.03 Lot Number: 26020464; DeRoyal BASIC ORTHO TRAY, REF 89-3389.11 Lot Number: 26010291; DeRoyal TOTAL KNEE PACK, REF 89-7114.02 Lot Number: 26012780; DeRoyal ACF TRAY, REF 89-7660.01 Lot Number: 26022656; DeRoyal HAND PACK, REF 89-7549.02 Lot Numbers: 26042330, 26147713; DeRoyal ORTHO PACK, REF 89-7546.02 Lot Numbers: 26025242, 26025717; DeRoyal THORACOTOMY PACK, REF 89-7536.02 Lot Number: 26022161; DeRoyal LAPAROSCOPIC GYN PACK, REF 89-7500.02 Lot Number: 26096063; DeRoyal ELG/AAA PACK, REF 89-7495.02 Lot Number: 26256371; DeRoyal PEDI OPEN HEART PACK, REF 89-7486.02 Lot Number: 26100624; DeRoyal TOTAL KNEE PACK, REF 89-7484.01 Lot Number: 25875196; DeRoyal TOTAL KNEE PACK, REF 89-7466.01 Lot Number: 26013301; DeRoyal CUSTOM TOTAL HIP PACK, REF 89-7465.03 Lot Number: 26096039, 26166244; DeRoyal PERIPHERAL VASCULAR PACK, REF 89-7451.02 Lot Number: 26166252; DeRoyal NEURO PACK, REF 89-7396.01 Lot Number: 26061573; DeRoyal LABOR & DELIVER PACK, REF 89-7448.03 Lot Number: 26166236; DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-7446.02 Lot Number: 26096549; DeRoyal GENERAL MINOR PACK, REF 89-7365.01 Lot Numbers: 25838838, 26095765; DeRoyal CUSTOM GENERAL MAJOR PACK, REF 89-7357.01 Lot Nu

    Recall: Z-0963-2012 · Initiated June 14, 2011

    Recall

    Recall Number
    Z-0963-2012
    Event Number
    60852
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 14, 2011
    Posted
    February 6, 2012
    Terminated
    June 27, 2013
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; DeRoyal C-SECTION TRAY, REF 89-5256.06 Lot Number: 26185242; DeRoyal C V MINOR TRAY, REF 89-5277.02 Lot Number: 25793211; DeRoyal COMBINED EXTREMITY PACK, REF 89-6773.02 Lot Numbers: 25744022, 26010670, 26194641; DeRoyal DISKECTOMY TRAY, REF 89-6196.03 Lot Number: 26097373; DeRoyal MAJOR DRAPE PACK, REF 89-7255.01 Lot Number: 26011736; DeRoyal EXTREMITY PACK PGYBK, REF 89-5275.05 Lot Number: 26063270; DeRoyal SCOPE SHOULDER TRAY, REF 89-5653.03 Lot Number: 26227422; DeRoyal KNEE SCOPE PACK, REF 89-5654.03 Lot Number: 26020510; DeRoyal BILATERAL DRAPE, REF 89-5379.02 Lot Number: 26042735, 26282421; DeRoyal LAPAROSCOPIC CHOLE PACK, REF 89-5259.05 Lot Number: 25817201; DeRoyal MAJOR HIP PACK, REF 89-4718.04 Lot Number: 25840313; DeRoyal SPINE PACK, REF 89-4150.06 Lot Number: 25933077; DeRoyal ARTHROSCOPY TRAY, REF 89-5317.02 Lot Number: 26078463; DeRoyal LARGE VASCULAR TRAY, Lot Number: 26078447; DeRoyal SMALL VASCULAR TRAY, REF 89-3694.13 Lot Number: 261449399; DeRoyal ASC VASCULAR PACK PGYBK, REF 89-6284.05 Lot Number: 25698986; DeRoyal ASC BREAST PACK, REF 89-6285.06, Lot Number: 26078578; DeRoyal ASC FOOT/ANKLE PACK, REF 89-6014.07 Lot Numbers: 26096856, 26147916; DeRoyal ACUTE BURN EXCISION TRAY, REF 89-3330.05 Lot Number: 26078367; DeRoyal RECONSTRUCTION TRAY, REF 89-3331.04 Lot Numbers: 25817383, 26019720; DeRoyal FOOT PACK, REF 89-6467.05 Lot Number: 25880438; DeRoyal TRAUMA PACK, REF 89-6776.04 Lot Number: 26010688; DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5257.08 Lot Numbers: 26125434, 26149102; DeRoyal CHILDRENs ORTHOPEDIC TRAY, REF 89-3479.08 Lot Numbers: 25873676, 25905092 DeRoyal KNEE SCOPE, REF 89-2910.09 Lot Number: 25695611; DeRoyal SPINE PACK PGYBK, REF 89-6720.01 Lot Number: 26022048; DeRoyal OPEN SHOULDER PROCEDURE PACK, REF 89-6629.01 Lot Number: 25839187; DeRoyal ORTHO TOTAL BASIC TRAY, REF 89-2650.15 Lot Numbers: 25893423, 26010207, 26077111; DeRoyal ORTHO TOTAL HIP/KNEE TRAY, REF 89-2644.17 A & B Lot Number: 25894012; DeRoyal MINOR/PLASTIC PACK, REF 89-6994.02 Lot Number: 25853544; DeRoyal OPEN HEART PACK, REF 89-6996.02 Lot Number: 25853608; DeRoyal GEN SURG UNIV PACK, REF 89-6991.02 Lot Number: 25696032; DeRoyal PERI VASCULAR PACK, REF 89-6998.03 Lot Number: 25853587; DeRoyal VASCULAR PACK, REF 50-4157.29 Lot Number: 25732507; DeRoyal OPEN HEART B, REF 50-13010.19 Lot Number: 26009978; DeRoyal GENERAL ORTHO PACK, REF 89-6883.02 Lot Number: 25695911; DeRoyal HIP COUNTABLES TRAY, REF 89-5382.03 Lot Number: 26020464; DeRoyal BASIC ORTHO TRAY, REF 89-3389.11 Lot Number: 26010291; DeRoyal TOTAL KNEE PACK, REF 89-7114.02 Lot Number: 26012780; DeRoyal ACF TRAY, REF 89-7660.01 Lot Number: 26022656; DeRoyal HAND PACK, REF 89-7549.02 Lot Numbers: 26042330, 26147713; DeRoyal ORTHO PACK, REF 89-7546.02 Lot Numbers: 26025242, 26025717; DeRoyal THORACOTOMY PACK, REF 89-7536.02 Lot Number: 26022161; DeRoyal LAPAROSCOPIC GYN PACK, REF 89-7500.02 Lot Number: 26096063; DeRoyal ELG/AAA PACK, REF 89-7495.02 Lot Number: 26256371; DeRoyal PEDI OPEN HEART PACK, REF 89-7486.02 Lot Number: 26100624; DeRoyal TOTAL KNEE PACK, REF 89-7484.01 Lot Number: 25875196; DeRoyal TOTAL KNEE PACK, REF 89-7466.01 Lot Number: 26013301; DeRoyal CUSTOM TOTAL HIP PACK, REF 89-7465.03 Lot Number: 26096039, 26166244; DeRoyal PERIPHERAL VASCULAR PACK, REF 89-7451.02 Lot Number: 26166252; DeRoyal NEURO PACK, REF 89-7396.01 Lot Number: 26061573; DeRoyal LABOR & DELIVER PACK, REF 89-7448.03 Lot Number: 26166236; DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-7446.02 Lot Number: 26096549; DeRoyal GENERAL MINOR PACK, REF 89-7365.01 Lot Numbers: 25838838, 26095765; DeRoyal CUSTOM GENERAL MAJOR PACK, REF 89-7357.01 Lot Nu

    Reason

    Custom surgical kits contain recalled Kimberly Clark surgical drapes which were found to contain metal shavings in the folds of the drapes.

    Action

    DeRoyal Industries Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL OF KIMBERLY-CLARK THREE-QUARTER DRAPE 79147" letter dated June 14, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify and quarantine all affected product. Further instructions by the firm asks customers to complete and return a Recall Response Spreadsheet via fax to 865-362-3744. Customers should contact their Deroyal Sales Representative for questions or assistance regarding this recall.

    Distribution

    Nationwide Distribution.

    Quantity

    3881 kits