FDA Enforcement
Class II
Ongoing
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Recall: Z-1547-2025
·
Reported April 16, 2025
Enforcement
- Recall Number
- Z-1547-2025
- Event ID
- 96541
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 16, 2025
- Initiation Date
- March 5, 2025
- Classification Date
- April 9, 2025
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Reason
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Code Info
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
US Nationwide distribution
Quantity
020 units