BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D

    Recall: Z-0647-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0647-2025
    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) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D

    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 CDS985431J, UDI/DI 10195327336110 (each) 40195327336111 (case), Lot Numbers: 23BBG608; 2) REF CDS985431K, UDI/DI 10195327451295 (each) 40195327451296 (case), Lot Numbers: 23JBF512, 23IBQ647; 3) REF CDS985431L, UDI/DI 10195327527273 (each) 40195327527274 (case), Lot Numbers: 24ABA205, 24ABW239, 24ABV349, 24CBR704, 24EBP485; 4) REF DYNJ44153G, UDI/DI 10195327412623 (each) 40195327412624 (case), Lot Numbers: 23KBB932; 5) REF DYNJ60924C, UDI/DI 10195327470333 (each) 40195327470334 (case), Lot Numbers: 23JBF913; 6) REF DYNJVB1280C, UDI/DI 10195327173951 (each) 40195327173952 (case), Lot Numbers: 23ELB178, 23CLA196, 23BLA668, 23BLA272; 7) REF DYNJVB1280D, UDI/DI 10195327482114 (each) 40195327482115 (case), Lot Numbers: 24CLA257, 23LLA915, 24CLA715, 24BLA712;

    Distribution

    US Nationwide distribution.

    Quantity

    478 units