BEUDAMED
    FDA Recall Terminated

    On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites.

    Recall: Z-2133-2008 · Initiated February 14, 2008

    Recall

    Recall Number
    Z-2133-2008
    Event Number
    48454
    Firm
    I-Flow Corporation
    FEI Number
    3011270181
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 14, 2008
    Posted
    September 11, 2008
    Terminated
    October 7, 2009
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630-8152

    Description

    On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites.

    Reason

    Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.

    Action

    Firm faxed customer notification letters to customers on February 14, 2008 advising that two lots of CB005 (lot numbers 792457 and 7A2667) may contain an incorrect fill port label. All other product labeling is correct for the CB005 pumps. Customers are asked to inspect the CB005 inventory to determine if they have any of the affected lots. If so, customers are not to use the product and quarantine any remaining inventory. Customers are also asked to provide a copy of the notification to end users who may have received CB005, lot numbers 792457 and 7A2667. A response form is also provided.

    Distribution

    Class II Recall - Nationwide Distribution --- including states of IL, TX, PA, OK, NC, GA, MI, FL, OH, and CA.

    Quantity

    792457 (430 units) and 7A2667 (390 units)