Z-1547-2025 Class II Ongoing
FDA device recall Z-1547-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on March 5, 2025 and is designated Class II. Reason for recall: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. The recall status is ongoing. Affected quantity: 020 units.
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.