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FDA (Device enforcement)Recalled 2025-03-05class ii

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R

Hazard

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

Details from the source

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: US Nationwide distribution Quantity: 020 units Lot/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.

UPC codes

10888277395367

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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