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Recall Observatory FDA recall evidence

Device product

MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R

Z-1546-2025

March 05, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96541
Status
Ongoing
Classification
Class II
Quantity
738 units
Official record key
device-enforcement:Z-1546-2025

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 10888277395350, Lot Numbers: 513468, 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515907, 516476, 516478, 516549, 517320, 517321, 517322, 517323, 517358, 517360, 517627, 517628, 517631, 518473, 518476, 518477, 518960, 519256, 519257, 519258, 519260, 519264, 519265, 519678, 519759, 519760, 519762, 519860, 519965, 519967, 520279, 520357, 520358, 520691, 520692, 521358, 521359, 522140, 522141, 522142, 522143, 522506, 522507, 522508, 522510, 524010, 524011, 524015, 524798, 524801, 524802, 524822, 525470, 525474, 527114, 527117, 528453, 528455, 528583, 528585, 528586, 528896, 528899, 528902, 528903, 528904, 529481, 529491, 529931, 529932, 530010, 530435, 531018, 531025, 531026, 531027, 531672, 532270, 532272, 532815, 532817, 532819, 532822.

Distribution pattern: US Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.