Medline ReNewal Coblator II Evac 70 Xtra Plasma Wand Disconnection Risk
Medline Industries is recalling 738 units of the ReNewal Coblator II Evac 70 Xtra Plasma Wand due to risk that drip chambers may disconnect from the saline line tubing under tension.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a structural/functional defect that could compromise intended use. No illnesses or injuries are reported in the source text, but the defect poses a risk of harm if the device disconnects during clinical use.
Plain-English summary
Medline Industries, LP is recalling the ReNewal Coblator II Evac 70 Xtra Plasma Wand with Integrated Saline Line & Integrated Cable (Item Number REF EICA58720R) due to a defect in the device's drip chamber connection. The drip chambers of affected devices may disconnect from the saline line tubing when under tension, which could compromise the device's intended function during use.
This recall affects 738 units that were distributed nationwide in the United States. The affected devices include the following 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 (UDI/DI 10888277395350).
Customers who have received these devices should discontinue use and contact Medline Industries for further guidance on replacement or return of the affected units.
The recalled product
- Product
- MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-disconnection
- saline-line-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 10888277395350
- Lot Numbers: 513468
- 513993
- 514445
- 514446
- 514449
- 515558
- 515650
- 515861
- 515907
- 516476
- 516478
- 516549
- 517320
- 517321
- 517322
- 517323
- 517358
- 517360
- 517627
Distribution
Distributed nationwide across the United States.
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