BEUDAMED
    FDA Enforcement Class II Ongoing

    Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

    Recall: Z-2203-2026 · Reported May 27, 2026

    Enforcement

    Recall Number
    Z-2203-2026
    Event ID
    98603
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 27, 2026
    Initiation Date
    April 8, 2026
    Classification Date
    May 15, 2026
    Address
    17200 Laguna Canyon Rd, Irvine, CA, 92618-5403, United States

    Description

    Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

    Reason

    Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

    Code Info

    Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371

    Distribution

    Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.

    Quantity

    183