Z-1547-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2025
- Initiation Date
- March 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 020 units
Product Description
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Reason for Recall
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Distribution Pattern
US Nationwide distribution
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.