BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.

    Recall: Z-0784-2025 · Reported January 8, 2025

    Enforcement

    Recall Number
    Z-0784-2025
    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) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.

    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 DYNJ58648B, UDI/DI 10193489624182 (EA) 40193489624183 (CS), Lot Numbers: 19BDB193; 2) REF DYNJ58648C, UDI/DI 10193489688542 (EA) 40193489688543 (CS), Lot Numbers: 19EDD585, 19IDA770, 20AMA033, 20AMC750, 20EMB449; 3) REF DYNJ66447, UDI/DI 10193489367379 (EA) 40193489367370 (CS), Lot Numbers: 20KMC595, 21AMB129; 4) REF DYNJ58648D, UDI/DI 10195327212124 (EA) 40195327212125 (CS), Lot Numbers: 22KMD675, 23DMD129, 23HMG766, 23JMD938; 5) REF DYNJ58648J, UDI/DI 10193489356793 (EA) 40193489356794 (CS), Lot Numbers: 20EBN856, 20JBG508, 20JBK503, 20JBT975, 20KBQ270, 21ABK829, 21EBP637, 21EBP646, 21JBO555, 21KBC098, 21KBV126, 21LBP144.

    Distribution

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

    Quantity

    1072 units