BEUDAMED
    FDA Recall Open, Classified

    20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

    Recall: Z-0733-2025 · Initiated November 6, 2024

    Recall

    Recall Number
    Z-0733-2025
    Event Number
    95707
    Firm
    Abbott Vascular Inc
    FEI Number
    2024168
    Product Code
    MAV
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    November 6, 2024
    Posted
    December 20, 2024
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

    Reason

    Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

    Action

    On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902

    Distribution

    US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.

    Quantity

    4,975