BEUDAMED
    FDA Recall Open, Classified

    VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    Recall: Z-1070-2024 · Initiated January 9, 2024

    Recall

    Recall Number
    Z-1070-2024
    Event Number
    93806
    Firm
    Ventec Life Systems, Inc.
    FEI Number
    3013095415
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 9, 2024
    Posted
    February 23, 2024
    Address
    22002 26th Ave Se, Bothell, WA, 98021-4903

    Description

    VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    Reason

    The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.

    Action

    On 12/22/2023, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION via Direct overnight mail, or FedEx, or email, or hand delivered, to customers informing them that Ventec Life Systems is recalling a specific lot (listed below) of the VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) since the bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Customer are instructed to: 1. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 2. Stop use of the affected Patient Breathing Package and replace it with a non-affected product. 3. Inspect current stock and quarantine/segregate any unused affected products to prevent their use. For questions/assistance - contact Ventec Life Systems directly at 844-MYVOCSN (844-698-6276), Monday through Friday between 8:00 a.m. - 5:00 p.m. PDT.

    Distribution

    U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan

    Quantity

    250 breathing circuits