FDA-Device2025-04-16Class II
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Sold states
US Nationwide distribution
Affected count
224 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1549-2025Don't want to check this manually?
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