Device product
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Z-1548-2025
Product summary
- Event
- Event 96541
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 315 units
- Official record key
device-enforcement:Z-1548-2025
Official wording
Reason: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Code information: UDI/DI 10888277395374, Lot Numbers: 506894, 509420, 512983, 513469, 514448, 514549, 515557, 515860, 515903, 516550, 517359, 517626, 519259, 519413, 519966, 520277, 521360, 522144, 522145, 525472, 527111, 527115, 527121, 528456, 528457, 528582, 529483, 529485, 529487, 529489, 529930, 530432, 530433, 530434, 531020, 531024, 531676.
Distribution pattern: US Nationwide distribution
Derived failure modes
-
Unknown
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.