BEUDAMED
    FDA Recall Terminated

    Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.

    Recall: Z-1351-2015 · Initiated February 5, 2015

    Recall

    Recall Number
    Z-1351-2015
    Event Number
    70472
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 5, 2015
    Posted
    March 30, 2015
    Terminated
    August 6, 2015
    Address
    1499 Delp Dr, Harleysville, PA, 19438

    Description

    Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.

    Reason

    Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.

    Action

    On or about 02/03/2015, Medcomp sales representatives notified the affected medical facilities and providing Medcomp's recall letter. This was accomplished by e-mail, telephone, or visit. Distributors for the international accounts were notified by Medcomp via e-mail. A copy of Medcomp's recall letter was attached. For AngioDynamics product- Medcomp notified AngioDynamics by e-mail of the product recall. Every consignee was requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received. AngioDynamics was requested to provide an account of the disposition for the total number of product they received.

    Distribution

    Worldwide Distribution.

    Quantity

    3152