BEUDAMED
    FDA Recall Terminated

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS 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-1752-2018 · Initiated March 29, 2018

    Recall

    Recall Number
    Z-1752-2018
    Event Number
    79789
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    DTL
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    March 29, 2018
    Posted
    May 9, 2018
    Terminated
    April 9, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS 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.

    Action

    On March 29, 2018, the recalling firm mailed recall notifications to affected customers. Customers were informed that the affected devices may have been manufactured with equipment that was out of calibration, which could result in the cap-adapter assembly of the device not being adequately tightened. Customers were advised of potential adverse events. Customers were instructed to 1) Examine inventory immediately to determine if they have affected product, and quarantine affected product. Immediately cease all distribution and use of the recalled lots. 2) Return the affected product to the recalling firm with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3) Complete the Acknowledgement and Receipt Form even if the customer does not have affected products on hand. 4) Immediately report adverse events to the recalling firm. Customers with further questions were directed to contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

    Distribution

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

    Quantity

    220