BEUDAMED
    FDA Recall Terminated

    Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.

    Recall: Z-0843-06 · Initiated March 22, 2006

    Recall

    Recall Number
    Z-0843-06
    Event Number
    34988
    Firm
    Celsion Corporation, Inc.
    FEI Number
    1122126
    Product Code
    MEQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2006
    Posted
    May 6, 2006
    Terminated
    February 7, 2007
    Address
    10220 Old Columbia Road, Suite L, Columbia, MD, 21046-2364

    Description

    Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.

    Reason

    Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.

    Action

    The recalling firm notified the contract distributor on 2/17/06 to cease shipments. The distributor subsequently notified accounts on 3/22/06 with lot and shipment specific recall letters. The letters advised that consignees discontinue use of the affected lots for return to the distributor. Consignees were requested to return the reply verification form enclosed.

    Distribution

    Products were distributed to one distributor in MA and eight medical device users in MA, IL, NJ, FL, NY, CO, OH, and MI.

    Quantity

    1515 kits