BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097

    Recall: Z-2760-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2760-2024
    Event ID
    94581
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 4, 2024
    Initiation Date
    April 8, 2024
    Classification Date
    August 28, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

    Code Info

    DYKM1426 , Lot Numbers: 21HME852; DYKM1426 , Lot Numbers: 21JMB937; DYKM1426 , Lot Numbers: 22AMC931; DYKM1426 , Lot Numbers: 22BMH636; DYKM1426 , Lot Numbers: 22GMC855; DYKM1426 , Lot Numbers: 22HMD453; DYKM1426 , Lot Numbers: 22JMA597; DYKM1426 , Lot Numbers: 22LMF030; DYKM1426 , Lot Numbers: 23JMB439; DYKM1426 , Lot Numbers: 24AMF833; DYNJ908583, Lot Numbers: 23BBI474; DYNJ908583, Lot Numbers: 23GBU194; DYNJ908583, Lot Numbers: 23HBI662; DYNJ908583A , Lot Numbers: 23HBU557; DYNJ908583A , Lot Numbers: 23JBD374; DYNJ908583A , Lot Numbers: 23KBO704; DYNJ908583A , Lot Numbers: 23KBW138; DYNJ908583A , Lot Numbers: 24ABB089; DYNJ908583A , Lot Numbers: 24BBD662; DYNJ908583A , Lot Numbers: 24BBS919; DYNJ908583A , Lot Numbers: 24CBB994; DYNJ909097, Lot Numbers: 23EBQ501; DYNJ909097, Lot Numbers: 23FBH520; DYNJ909097, Lot Numbers: 23GBD905; DYNJ909097, Lot Numbers: 23HBP109; DYNJ909097, Lot Numbers: 23HBY982; DYNJ909097, Lot Numbers: 23IBM281

    Distribution

    Worldwide