Medline ReNewal ENT Coblator II Suction Device Drip Chamber Disconnection
Medline ReNewal is recalling 224 units of ENT Coblator II PROcise mAx devices because the drip chambers may disconnect from the saline line tubing under tension, creating a potential surgical hazard.
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 medical device recall involving a structural/functional defect (drip chamber disconnection) that poses a risk of harm during surgical procedures. Although no injuries have been reported in the source text, the recall addresses a risk-of-harm condition in a critical-use device, meeting the High severity threshold.
Plain-English summary
Medline ReNewal has identified that the drip chambers of affected MEDLINE ReNewal ENT Coblator II PROcise mAx devices (Item Number REF EICA88980R, UDI/DI 10080196415106) may disconnect from the saline line tubing when under tension. This disconnection could affect proper delivery of saline during use.
The recalled devices were distributed nationwide in the United States. The recall involves 224 units across 29 specific lot numbers: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, and 531022.
If you have one of these devices, contact Medline Industries, LP for further instructions. Do not use affected units until receiving guidance from the manufacturer.
The recalled product
- Product
- MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-disconnection
- saline-delivery-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 10080196415106
- Lot Numbers: 506549
- 508766
- 509420
- 512036
- 512983
- 514060
- 514709
- 516475
- 516802
- 517626
- 518478
- 518961
- 519248
- 519259
- 519411
- 519412
- 519413
- 519966
- 519969
Distribution
Distributed nationwide across the United States.
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