BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C

    Recall: Z-0626-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0626-2025
    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) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C

    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 DYNJ00281O, UDI/DI 10193489962963 (each) 40193489962964 (case), Lot Numbers: 22KMA417, 22FMD671; 2) REF DYNJ0101291F, UDI/DI 10195327286644 (each) 40195327286645 (case), Lot Numbers: 23FDA396, 23HDA759, 23EDB388, 23LDB909; 3) REF DYNJ0488546K, UDI/DI 10195327505097 (each) 40195327505098 (case), Lot Numbers: 23IBP983; 4) REF DYNJ84762, UDI/DI 10195327413088 (each) 40195327413089 (case), Lot Numbers: 23IMA327, 23IMA727; 5) REF DYNJ906907C, UDI/DI 10195327376819 (each) 40195327376810 (case), Lot Numbers: 23DBM940, 23FBG165, 23IBQ680

    Distribution

    US Nationwide distribution.