Device 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.
Z-2567-2025
Product summary
- Event
- Event 97411
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 596 units
- Official record key
device-enforcement:Z-2567-2025
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. 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 pattern: US distribution to: AL, CA, DE, OR, TN, TX
Derived failure modes
-
Unknown
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.