Z-2566-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2025
- Initiation Date
- July 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2520 units
Product 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 for Recall
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.
Distribution Pattern
US distribution to: AL, CA, DE, OR, TN, TX
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: