BEUDAMED
    FDA Recall Terminated

    Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS. Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.

    Recall: Z-1812-2009 · Initiated May 7, 2009

    Recall

    Recall Number
    Z-1812-2009
    Event Number
    52160
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    LIO
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    May 7, 2009
    Posted
    August 18, 2009
    Terminated
    January 15, 2010
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS. Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.

    Reason

    Incorrect expiration date on the product

    Action

    The recalling firm issued Important Medical Device Product Recall Notice letters dated 5/7/09 via regular mail to their direct accounts explaining the reason for recall and requesting they discard all remaining units of the affected lot number in their inventory. A Product Inventory Checklist was enclosed to be returned in the enclosed self-addressed, stamped envelope to report the amount of product that was discarded. The Technical Services Department should be contacted at 800-447-3641 if there are any inquiries concerning the letter.

    Distribution

    Nationwide Distribution

    Quantity

    103 packages