BEUDAMED
    FDA Recall Terminated

    Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

    Recall: Z-0116-2016 · Initiated August 19, 2015

    Recall

    Recall Number
    Z-0116-2016
    Event Number
    72247
    Firm
    Concentric Medical Inc
    FEI Number
    3003271051
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 19, 2015
    Posted
    October 9, 2015
    Terminated
    October 9, 2015
    Address
    301 E Evelyn Ave, Mountain View, CA, 94041-1530

    Description

    Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

    Reason

    One Distal Access Catheter intended for distribution in Korea, was found at a US location.

    Action

    Issue was discovered by a sales representative during a visit for a case in Kentucky, where multiple Distal Access Catheters (DAC's) were being used. It was noticed that the reference number on one DAC carton did not match, even through the product labeling appeared to be the same. The mismatched unit was removed and returned to Concentric (Stryker). A formal recall letter was not issued as the product was returned after discovery. For further questions please call (510) 413-2263.

    Distribution

    US Distribution to one location in KY.

    Quantity

    1