Device product
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Z-1547-2025
Product summary
- Event
- Event 96541
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 020 units
- Official record key
device-enforcement:Z-1547-2025
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 10888277395367, Lot Numbers: 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515902, 515907, 516478, 516549, 517320, 518476, 519258, 519265, 519678, 519759, 519760, 520279, 520282, 520357, 520692, 521356, 521359, 522140, 522141, 522143, 522507, 522508, 524010, 524011, 524015, 524797, 524798, 524802, 528455, 528586, 528587, 528896, 528904, 529932, 530010, 531025, 531027, 532815, 532817.
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.