MEDLINE ReNewal ENT Coblator II Saline Drip Chamber Disconnection
Medline ReNewal is recalling 224 units of ENT surgical devices because drip chambers may disconnect from the saline line tubing under tension, potentially disrupting saline 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 is a medical device where a documented malfunction—saline line disconnection—could disrupt critical function during surgery. The potential for saline delivery disruption during ENT procedures represents a risk-of-harm scenario. No illnesses or injuries have been reported, which prevents a higher classification, but the documented risk of equipment failure during a medical procedure justifies a High severity rating.
Plain-English summary
Medline ReNewal is recalling 224 units of the MEDLINE ReNewal ENT Coblator II PROcise mAx with Integrated Cable Suction & Saline, a surgical device used in ENT procedures and distributed nationwide.
The drip chambers of affected devices may disconnect from the saline line tubing when under tension. This could interrupt saline delivery during procedures.
Affected devices are identified by the following 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. Healthcare facilities should check inventory for these lot numbers and discontinue use of any affected devices.
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
- drip-chamber-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 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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