BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591

    Recall: Z-0624-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0624-2025
    Event ID
    95621
    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
    December 11, 2024
    Initiation Date
    October 9, 2024
    Classification Date
    December 5, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591

    Reason

    Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

    Code Info

    1) REF DYNJ39185D, UDI/DI 10195327157166 (each) 40195327157167 (case), Lot Numbers: 22GBA088, 22FBS934, 22HBA086; 2) REF DYNJ44997J, UDI/DI 1019532738093 (each) 40195327380930 (case), Lot Numbers: 23GBU050, 23KBI422, 23JBL004, 23IBB532, 23LBK392, 24BBA287, 24CBM430; 3) REF DYNJ58409C, UDI/DI 10193489957242 (each) 40193489957243 (case), Lot Numbers: 22GBT985, 22LBD309, 23JBP407; 4) REF DYNJ66252A, UDI/DI 10193489887853 (each) 40193489887854 (case), Lot Numbers: 22OBL262; 5) REF DYNJ909591, UDI/DI 10195327413613 (each) 40195327413614 (case), Lot Numbers: DYNJ909591

    Distribution

    US Nationwide distribution.

    Quantity

    1271 units