BEUDAMED
    FDA Recall Open, Classified

    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

    Recall: Z-1873-2025 · Initiated May 2, 2025

    Recall

    Recall Number
    Z-1873-2025
    Event Number
    96783
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    FOS
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    May 2, 2025
    Posted
    May 29, 2025
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

    Reason

    Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

    Action

    The firm started notifying customers on May 2, 2025 via Urgent Medical Device Product Recall letters. Customers were instructed to remove any devices currently in use. In addition, customers should review their inventory and segregate/quarantine all affected product. If product has been further distributed, the distributor should notify all downstream customers. Customers are asked to return an acknowledgement form whether they have affected product or not. Customers should contact the firm to arrange for return and credit or questions regarding suitable alternative products. For questions related to this recall, please contact the market action team at: [email protected] or call 800-292-9332.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

    Quantity

    51378