BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.

    Recall: Z-0793-2025 · Reported January 8, 2025

    Enforcement

    Recall Number
    Z-0793-2025
    Event ID
    95852
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2025
    Initiation Date
    November 21, 2024
    Classification Date
    December 30, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.

    Reason

    Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

    Code Info

    1) REF DYNJ0867145G, UDI/DI 10889942625413 (EA) 40889942625414 (CS), Lot Numbers: 19BDA435, 19DDD135; 2) REF DYNJ35184F, UDI/DI 10889942567737 (EA) 40889942567738 (CS), Lot Numbers: 19CBC965, 19QBC217; 3) REF DYNJ904827, UDI/DI 10889942743742 (EA) 40889942743743 (CS), Lot Numbers: 19DBD844, 19HBO089, 19HBQ573, 19IBQ930, 19SBE329.

    Distribution

    Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

    Quantity

    182 units