Medline Coblator II Plasma Wand Recalled for Drip Chamber Disconnection Risk
Medline Industries recalled 738 units of the ReNewal Coblator II Evac 70 Plasma Wand due to drip chambers that may disconnect from 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 a Class II medical device with a documented structural defect (drip chamber disconnection) that could interrupt saline delivery during surgical use—a risk-of-harm scenario. The source text provides no report of actual injuries or illnesses, placing it at Score 3 per the rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
Medline Industries is recalling 738 units of the ReNewal Coblator II Evac 70 Xtra Plasma Wand distributed nationwide in the United States.
The drip chambers of these devices may disconnect from the saline line tubing when under tension, potentially interrupting saline delivery during use.
The affected product (Item Number REF EICA58720R, UDI/DI 10888277395350) was distributed to healthcare facilities nationwide. Multiple lot numbers are affected; the complete list is available on the FDA website.
Healthcare facilities that received affected units should contact Medline Industries for instructions on obtaining a replacement.
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
- connection-failure
- equipment-disconnection
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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