Z-2567-2025 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
- 596 units
Product Description
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.
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. 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: