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Recall Observatory FDA recall evidence

Device product

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.

Z-2566-2025

July 25, 2025

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 97411
Status
Ongoing
Classification
Class I
Quantity
2520 units
Official record key
device-enforcement:Z-2566-2025

Official wording

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.