BEUDAMED
    FDA Recall Open, Classified

    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

    Recall: Z-1111-2026 · Initiated December 19, 2025

    Recall

    Recall Number
    Z-1111-2026
    Event Number
    98150
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 19, 2025
    Posted
    January 16, 2026
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

    Reason

    Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body

    Action

    On 12/19/2025, correction notices were emailed to customers who were asked to do the following: 1) Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the Customer Response Form via email to [email protected] For further inquiries, please contact the firm: Global Complaint Management: [email protected] 1-(866)-216-8806; Customer Service: [email protected], 1-(800)-258-5361

    Distribution

    Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.

    Quantity

    14,684,607 items