BEUDAMED
    FDA Recall Terminated

    AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803

    Recall: Z-0711-04 · Initiated February 26, 2004

    Recall

    Recall Number
    Z-0711-04
    Event Number
    28419
    Firm
    Enpath Medical, Inc.
    FEI Number
    2183787
    Product Code
    GAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 26, 2004
    Posted
    July 20, 2004
    Terminated
    June 25, 2006
    Address
    15301 Highway 55, Plymouth, MN, 55447-1418

    Description

    AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803

    Reason

    The product is labeled as sterile product but had not been sterilized.

    Action

    The only direct consignee, to whom the product was shipped, was notified of the recall by telephone and fax on February 26, 2004. The consignee was requested to the return the product and to sub-recall the product from their customers.

    Distribution

    All of the product was shipped to a distributor in New York.

    Quantity

    20 ten-pack kits