BEUDAMED
    FDA Enforcement Class II Terminated

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    Recall: Z-1756-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1756-2018
    Event ID
    79789
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    March 29, 2018
    Classification Date
    May 8, 2018
    Termination Date
    April 9, 2019
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    Reason

    Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.

    Code Info

    Lots 7797164, 7844038, 7844039, 7844040, 7844041, 7844042, 7846434, 7846435, 7853869, 7853870, 7853871, 7853872, 7853873, 7853874, 7857491, 7857492, 7857493, 7857494, 7857495, 7857496, 7857497, 7857498, 7857499, 7857500, 7863742, 7863744, 7863745, 7863747, 7863748, 7863749, 7863750, 7863751, 7871644, 7871645, 7871646, 7871647, 7881937, 7881938, 7881939, 7881940, 7881941, 7881942, 7888498, 7888505, 7888506, 7888507, 7917423, 7917424, 7917425, 7917426, 7917434, 7925136, 7925137, 7925138, 7925139, 7925140, 7940326, 7940327, 7940328, 7940345, 7940346, 7949048, NS7835002, NS7875343, NS7881929, NS7888468, NS7928016, NS7940350

    Distribution

    Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.

    Quantity

    6345