BEUDAMED
    FDA Recall Terminated

    Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.

    Recall: Z-2883-2011 · Initiated June 28, 2011

    Recall

    Recall Number
    Z-2883-2011
    Event Number
    59212
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 28, 2011
    Posted
    July 30, 2011
    Terminated
    April 16, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.

    Reason

    Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.

    Action

    An "Urgent Medical Device Recall" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the "Recall Acknowledgement & Stock Status Form", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187.

    Distribution

    United States (states of CA, DE, FL, MI, NC, and TN).

    Quantity

    41