BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pack Number DYNJ0774005G; 6) PICC/RAD SPEC PROC 0906165-LF, Pack Number DYNJ32773G; 7) VAP PACK-LF, Pack Number PHS656578F

    Recall: Z-1439-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1439-2025
    Event ID
    96374
    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
    April 2, 2025
    Initiation Date
    February 11, 2025
    Classification Date
    March 25, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pack Number DYNJ0774005G; 6) PICC/RAD SPEC PROC 0906165-LF, Pack Number DYNJ32773G; 7) VAP PACK-LF, Pack Number PHS656578F

    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

    1) Pack Number DYNJ0826753O : UDI/DI 10193489384291 (each) 40193489384292 (case), Lot Number 23GMB253A; 2) Pack Number DYNJ56717A : UDI/DI 10889942897940 (each) 40889942897941 (case), Lot Number 21EBM603A; 3) Pack Number CVI5065 : UDI/DI 10195327504366 (each) 40195327504367 (case), Lot Number 23LMH242A; 4) Pack Number DYNJ46648D : UDI/DI 10193489755244 (each) 40193489755245 (case), Lot Number 20HMC528A; 5) Pack Number DYNJ0774005G : UDI/DI 10193489271485 (each) 40193489271486 (case), Lot Number 21EMA842Z; 6) Pack Number DYNJ32773G : UDI/DI 10193489766134 (each) 40193489766135 (case), Lot Number 21IMG907A; 7) Pack Number PHS656578F : UDI/DI 10889942804535 (each) 40889942804536 (case), Lot Number 20LKB006A

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    398