BEUDAMED
    FDA Recall Terminated

    Peritoneal Lavage Kits, Model number AK-09001

    Recall: Z-1409-04 · Initiated August 2, 2004

    Recall

    Recall Number
    Z-1409-04
    Event Number
    29819
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    GBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 2, 2004
    Posted
    August 25, 2004
    Terminated
    August 22, 2005
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Peritoneal Lavage Kits, Model number AK-09001

    Reason

    wrong introducer needle in some kits

    Action

    The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.

    Distribution

    The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.

    Quantity

    9100 units