BEUDAMED
    FDA Recall Terminated

    AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.

    Recall: Z-1112-2012 · Initiated February 6, 2012

    Recall

    Recall Number
    Z-1112-2012
    Event Number
    61123
    Firm
    Angiodynamics Worldwide Headquarters
    FEI Number
    3008319439
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 6, 2012
    Posted
    February 28, 2012
    Terminated
    February 10, 2016
    Address
    14 Plaza Drive, Latham, NY, 12110-3421

    Description

    AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.

    Reason

    The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.

    Action

    Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to [email protected]

    Distribution

    Nationwide Distribution -- Florida, Iowa, Maryland, New York, and Texas.

    Quantity

    11 units