BEUDAMED
    FDA Recall Open, Classified

    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

    Recall: Z-1100-2026 · Initiated December 19, 2025

    Recall

    Recall Number
    Z-1100-2026
    Event Number
    98168
    Firm
    ICU Medical Inc.
    FEI Number
    3012307300
    Product Code
    JKA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 19, 2025
    Posted
    January 15, 2026
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

    Reason

    Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

    Action

    On December 19. 2025, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that affected lots may have a crack present on the syringe collar. Customers were instructed to discontinue use of affected lots, and to destroy products following their institution's process for destruction. If destruction is not immediately possible, affected product should be quarantined until disposal.

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

    Quantity

    64290 total