BEUDAMED
    FDA Recall Open, Classified

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

    Recall: Z-1921-2026 · Initiated March 11, 2026

    Recall

    Recall Number
    Z-1921-2026
    Event Number
    98659
    Firm
    Windstone Medical Packaging, Inc.
    FEI Number
    1000125955
    Product Code
    KDD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 11, 2026
    Posted
    April 22, 2026
    Address
    1602 4th Ave N, Billings, MT, 59101-1521

    Description

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

    Reason

    The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

    Action

    An URGENT: MEDICAL DEVICE CORRECTION notification letter was sent to customers on 3/11/26. AMS requests that you undertake the following activities: 1. Review your inventory for the affected kits, all lots are impacted. 2. Communicate the notification with all personnel that utilize B Braun Admin. Sets contained within AMS kits. 3. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product notification. Your notification to your customers should include a copy of this notification letter. 4. Please complete and return the AMS Urgent Medical Device Product Notification Response Required form within 5 business days and return via email to [email protected] even if you have no affected product on hand. Please complete the attached AMS Urgent Medical Device Product Notification Response Required form and return it to Aligned Medical Solutions at the Fax number provided on the form. If you do not have the affected product, you must complete and return the form. If you have any questions or concerns, please do not hesitate to contact us at [email protected].

    Distribution

    US Nationwide distribution in the states of GA, OR, TN, and WA.

    Quantity

    520 units