BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC010469; 6. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480; 7. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480A; 8. ADULT INTUBATION, Kit Number ACC010540; 9. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593A; 10. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593B; 11. INTUBATION TRAY, Kit Number DYNDA1847A; 12. INTUBATION TRAY (ADULT), Kit Number DYNJAA245A.

    Recall: Z-2566-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2566-2025
    Event ID
    97411
    Classification
    Class I
    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
    October 1, 2025
    Initiation Date
    July 25, 2025
    Classification Date
    September 19, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC010469; 6. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480; 7. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480A; 8. ADULT INTUBATION, Kit Number ACC010540; 9. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593A; 10. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593B; 11. INTUBATION TRAY, Kit Number DYNDA1847A; 12. INTUBATION TRAY (ADULT), Kit Number DYNJAA245A.

    Reason

    Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.

    Code Info

    1. ACC010369B, UDI/DI 10193489777512 (EA) 40193489777513(CA), Lot Numbers: 2. ACC010379A; 10193489777529 (EA) 40193489777520(CA), Lot Numbers: 3. ACC010392; 10193489218053 (EA) 40193489218054(CA), Lot Numbers: 4. ACC010467A; 10193489834550 (EA) 40193489834551(CA), Lot Numbers: 5. ACC010469; 10193489414677 (EA) 40193489414678(CA), Lot Numbers: 6. ACC010480; 10193489499933 (EA) 40193489499934(CA), Lot Numbers: 7. ACC010480A; 10195327009366 (EA) 40195327009367(CA), Lot Numbers: 8. ACC010540; 10193489977547 (EA) 40193489977548(CA), Lot Numbers: 9. ACC010593A; 10195327168995 (EA) 40195327168996(CA), Lot Numbers: 10. ACC010593B; 10195327195472 (EA) 40195327195473(CA), Lot Numbers: 11. DYNDA1847A; 10193489481259 (EA) 40193489481250(CA), Lot Numbers: 12. DYNJAA245A. 10193489804584 (EA) 40193489804585(CA), Lot Numbers:

    Distribution

    US distribution to: AL, CA, DE, OR, TN, TX

    Quantity

    2520 units