BEUDAMED
    FDA Recall Terminated

    Assorted sterile surgical kits/ trays: DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Ortho III, REF 89-2761.04, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Cath Lab Tray, REF 89-4100.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 89-4191.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tray, REF 89-4199.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP GYN, REF 89-2995.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Pack, REF 89-3068.11, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Head and Neck Tray, REF 89-3281.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Sinus Tray, REF 89-3952.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy, REF 89-4052.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4138.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Plastics Tray, REF 89-4197.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Laparotomy Pack, REF 89-4312.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal OR Tray, REF 89-4422.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Breast Augmentation Pack, REF 89-4447.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal ORTHO Pack, REF 89-4482.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Joint Tray, REF 89-4613.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Hip Joint Tray, REF 89-4614.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Podiatry Tray, REF 89-4976.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 94-0148.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4998.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Lap Banding Pack, REF 89-5693.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 89-5703.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Shoulder Pack, REF 89-5715.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C/V Pack Tray, REF 20-011700.12, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Pack, REF 20-12059.16A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-3146.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Pacemaker, REF 89-4024.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Lithotomy Tray, REF 89-4193.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Angiography Drape Pack, REF 89-4278.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Minor General Pack, REF 89-4289.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 50-12456.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 89-4697.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.08, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Vascular Tray, REF 89-3561.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.09, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Ortho Ba

    Recall: Z-1204-2007 · Initiated July 3, 2007

    Recall

    Recall Number
    Z-1204-2007
    Event Number
    39374
    Firm
    DeRoyal Lafollette
    FEI Number
    3005011024
    Product Code
    KDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 3, 2007
    Posted
    August 29, 2007
    Terminated
    June 12, 2008
    Address
    1501 East Central Ave La, Follette, TN, 37766

    Description

    Assorted sterile surgical kits/ trays: DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Ortho III, REF 89-2761.04, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Cath Lab Tray, REF 89-4100.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 89-4191.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tray, REF 89-4199.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP GYN, REF 89-2995.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Pack, REF 89-3068.11, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Head and Neck Tray, REF 89-3281.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Sinus Tray, REF 89-3952.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy, REF 89-4052.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4138.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Plastics Tray, REF 89-4197.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Laparotomy Pack, REF 89-4312.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal OR Tray, REF 89-4422.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Breast Augmentation Pack, REF 89-4447.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal ORTHO Pack, REF 89-4482.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Joint Tray, REF 89-4613.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Hip Joint Tray, REF 89-4614.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Podiatry Tray, REF 89-4976.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 94-0148.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4998.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Lap Banding Pack, REF 89-5693.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 89-5703.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Shoulder Pack, REF 89-5715.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C/V Pack Tray, REF 20-011700.12, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Pack, REF 20-12059.16A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-3146.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Pacemaker, REF 89-4024.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Lithotomy Tray, REF 89-4193.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Angiography Drape Pack, REF 89-4278.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Minor General Pack, REF 89-4289.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 50-12456.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 89-4697.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.08, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Vascular Tray, REF 89-3561.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.09, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Ortho Ba

    Reason

    Packaging failure. Lack of sterility assurance

    Action

    Written notification of the recall was sent (via UPS Ground) beginning 7/03/2007 to consignees to advise them of problem and the recall. The letter stated that the recall was to the User level (which in this case, are the hospitals) and requested return of the product.

    Distribution

    Nationwide

    Quantity

    2023 cases