BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098

    Recall: Z-2762-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2762-2024
    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) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098

    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

    DYNJ908584 , Lot Numbers: 22DBL462; DYNJ908584 , Lot Numbers: 22JBS694; DYNJ908584 , Lot Numbers: 23CBQ227; DYNJ908584 , Lot Numbers: 23FBT227; DYNJ908584A, Lot Numbers: 23HBQ685; DYNJ908584A, Lot Numbers: 23JBT134; DYNJ908584A, Lot Numbers: 23LBE682; DYNJ908584A, Lot Numbers: 24CBH741; DYNJ909098 , Lot Numbers: 22LBS559; DYNJ909098 , Lot Numbers: 23EBQ496; DYNJ909098 , Lot Numbers: 23FBG194; DYNJ909098 , Lot Numbers: 23GBK039; DYNJ909098 , Lot Numbers: 23GBQ855; DYNJ909098 , Lot Numbers: 23IBK300; DYNJ909098 , Lot Numbers: 23IBQ772

    Distribution

    Worldwide