BEUDAMED
    FDA Recall Open, Classified

    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

    Recall: Z-0112-2024 · Initiated September 13, 2023

    Recall

    Recall Number
    Z-0112-2024
    Event Number
    93019
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    FMF
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 13, 2023
    Posted
    October 13, 2023
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

    Reason

    Syringe contains conical tip that is not compatible with certain needleless IV connector(s).

    Action

    Cardinal Health notified consignees on about 09/13/2023 via letter titled "URGENT MEDICAL DEVICE PRODUCT CORRECTION." Customers were instructed to review inventory for the affected product code and lot, ensure all personnel are informed cease utilizing the affected product with needleless IV connectors, post a copy of the notification in the storeroom where the product is stored, and notify any customers if the product has been further distributed/forwarded. Additionally, customers were asked to complete and return the included acknowledgment form.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY

    Quantity

    3.927,994 units