Device product
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Z-1549-2025
Product summary
- Event
- Event 96541
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 224 units
- Official record key
device-enforcement:Z-1549-2025
Official wording
Reason: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Code information: UDI/DI 10080196415106, 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, 531022.
Distribution pattern: US Nationwide distribution
Derived failure modes
-
Unknown
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.