BEUDAMED
    FDA Recall Terminated

    The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths

    Recall: Z-0954-04 · Initiated January 29, 2004

    Recall

    Recall Number
    Z-0954-04
    Event Number
    28980
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    FED
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 29, 2004
    Posted
    July 20, 2004
    Terminated
    May 3, 2012
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths

    Reason

    The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.

    Action

    A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.

    Distribution

    Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA.

    Quantity

    7 boxes, 5 sheaths per box