BEUDAMED
    FDA Recall Terminated

    Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.

    Recall: Z-1361-2015 · Initiated February 17, 2015

    Recall

    Recall Number
    Z-1361-2015
    Event Number
    70610
    Firm
    King Systems Corp.
    FEI Number
    1824226
    Product Code
    BZA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 17, 2015
    Posted
    April 1, 2015
    Terminated
    October 27, 2015
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060-4253

    Description

    Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.

    Reason

    Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. If the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure.

    Action

    Kingsystems sent an Urgent Medical Device Recall letter dated February 17, 2015 to affected customers. The letter identified the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call your King Systems customer service representative at 800.642.5464.

    Distribution

    US Nationwide in the states of IL, IN, KY, MI, PA, and TN

    Quantity

    900 units