Medline ReNewal Coblator II ENT Device Drip Chamber Disconnection Risk
Medline is recalling 20 units of ReNewal Coblator II ENT devices because drip chambers may disconnect from saline tubing under tension, potentially disrupting fluid delivery during procedures.
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 FDA Class II recall involves a potential device failure (drip chamber disconnection) with no reported illnesses, injuries, or deaths. Per the severity rubric, Class II recalls without reported harm involving risk-of-harm medical devices are classified as High (3) rather than Severe (4), as the hazard remains theoretical.
Plain-English summary
Medline Industries, LP is recalling 20 units of the ReNewal Coblator II ENT Evac 70 Xtra HP with Integrated Cable (Blue/Grey), model REF EICA58740R, due to a potential device safety issue.
The drip chambers of affected units may disconnect from the saline line tubing when under tension. This disconnection could disrupt fluid delivery during ear, nose, and throat (ENT) surgical procedures, potentially compromising procedure effectiveness or patient safety.
The recalled devices were distributed nationwide across multiple production lots, with lot numbers ranging from 513993 to 532817.
Facilities and healthcare providers in possession of affected devices should immediately stop using them and contact Medline Industries for return or replacement instructions. No injuries or adverse events have been reported in connection with this issue.
The recalled product
- Product
- MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-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 10888277395367
- Lot Numbers: 513993
- 514445
- 514446
- 514449
- 515558
- 515650
- 515861
- 515902
- 515907
- 516478
- 516549
- 517320
- 518476
- 519258
- 519265
- 519678
- 519759
- 519760
- 520279
Distribution
Distributed nationwide across the United States.
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