BEUDAMED
    FDA Recall Terminated

    Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.

    Recall: Z-1077-06 · Initiated April 24, 2006

    Recall

    Recall Number
    Z-1077-06
    Event Number
    35241
    Firm
    Catheter Research, Inc
    FEI Number
    3008998256
    Product Code
    LKF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 24, 2006
    Posted
    June 1, 2006
    Terminated
    December 4, 2007
    Address
    6131 W 80th St, Indianapolis, IN, 46278-1344

    Description

    Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.

    Reason

    The uterine stop component was not included with the device.

    Action

    Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product.

    Distribution

    Minnesota and Spain.

    Quantity

    660