Medline Medical Convenience Kits with Defective Laryngoscope Handles
Medline Industries is recalling specific medical convenience kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles because the light fails to illuminate as intended, potentially affecting resuscitation and airway management procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of medical devices used in critical procedures (resuscitation and airway management). Class I recalls are by definition associated with serious injury or death risk and must receive a score of at least 4 per the rubric.
Plain-English summary
Medline Industries, LP is recalling specific lots of medical convenience kits that contain Flexicare BritePro Solo Fiber Optic Laryngoscope Handles. The affected kits include: Newborn Resuscitation Kit (Kit Number ACC010381C), Drawer 5 – Position 3 (Kit Number ACC010532), Drawer #4C Adult (Kit Number ACC010671), and Drawer #2 (Kit Number ACC010728). A total of 596 units were distributed to healthcare facilities in Alabama, California, Delaware, Oregon, Tennessee, and Texas.
The reason for this recall is that the light on the laryngoscope handles fails to illuminate as intended. This defect could compromise the device's ability to function properly during critical medical procedures that depend on visualization.
Customers who have received these kits should stop using the affected laryngoscope handles and contact Medline Industries for replacement or further instructions. Specific lot numbers and UDI codes for each kit type are available in the FDA recall notice.
The recalled product
- Product
- Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-malfunction
- inadequate-illumination
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 (9)
- 1. ACC010381C: UDI/DI 10193489922127 (EA)
- 40193489922128 (CS)
- Kit Lot Numbers: 2. ACC010532: UDI/DI 10193489902358 (EA)
- 40193489902359 (CS)
- Kit Lot Numbers: 3. ACC010671: UDI/DI 10195327351090 (EA)
- 40195327351091 (CS)
- Kit Lot Numbers: 4. ACC010728: UDI/DI 10195327506544 (EA)
- 40195327506545 (CS)
- Kit Lot Numbers:
Distribution
Distributed in 6 states:
- AL
- CA
- DE
- OR
- TN
- TX
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