Intubation trays recalled after laryngoscope handle lights failed to illuminate
Medline is recalling 2,520 intubation and airway kits containing Flexicare BritePro Solo fiber optic laryngoscope handles because the light may fail to illuminate as intended.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Medline Industries is recalling specific items and lots of medical convenience kits that contain Flexicare BritePro Solo Fiber Optic Laryngoscope Handles, because the handle light can fail to illuminate as intended.
Twelve kit configurations are affected, including Adult Intubation Tray (ACC010369B), Adult ICU Intubation Tray (ACC010379A), Intubation Tray (ACC010392), Intubation Kit (ACC010467A), Adult Airway Tray (ACC010469), Tray 2 Intubation Drawer (ACC010480 and ACC010480A), Adult Intubation (ACC010540), Difficult Airway Tray #1 (ACC010593A and ACC010593B), Intubation Tray (DYNDA1847A) and Intubation Tray Adult (DYNJAA245A). The recall covers 2,520 units distributed to Alabama, California, Delaware, Oregon, Tennessee and Texas. The FDA has classified the recall as Class I.
Hospitals and emergency departments holding the listed kit numbers and lots should identify affected stock and follow Medline's instructions, ensuring an alternative working laryngoscope is available where these kits are stocked for airway management.
The recalled product
- 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…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,520
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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)
Distribution
Part of a larger recall action
This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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