BEUDAMED
    FDA Recall Terminated

    Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies

    Recall: Z-2982-2011 · Initiated May 13, 2011

    Recall

    Recall Number
    Z-2982-2011
    Event Number
    59386
    Firm
    North Coast Medi-Tek Inc
    FEI Number
    1526414
    Product Code
    LOR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2011
    Posted
    August 10, 2011
    Terminated
    February 16, 2012
    Address
    8603 East Ave, Mentor, OH, 44060-4366

    Description

    Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies

    Reason

    During routine bioburden testing, unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as >150,000 CFU. Our Alert Level is 17,000 CFU and the Action Level is 23,000 CFU.

    Action

    North Coast Medi - Tek Inc. sent a URGENT PRODUCT RECALL letter dated May 13, 2011 to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customers were instructed to stop shipment of all remaining product and return to recalling firm. They were also requested to contact their customers and notify them of the recall and retieve all remaining product. For further questions please call (440) 974-0750.

    Distribution

    Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX

    Quantity

    2,190 trays